{"id":23005,"date":"2018-04-19T11:45:04","date_gmt":"2018-04-19T18:45:04","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=23005"},"modified":"2025-11-19T13:51:44","modified_gmt":"2025-11-19T21:51:44","slug":"approved-huds","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/","title":{"rendered":"UW IRB Approved Clinical Use HUDs"},"content":{"rendered":"

The Humanitarian Use Devices<\/a> (HUDs) listed in this table<\/a> have all been approved by the UW IRB for clinical use at UW Medicine. HSD does its best to keep this table up-to-date, by adding HUDs described in new IRB applications and removing HUDs that later receive full FDA approval (“premarket approval”, or PMA).<\/p>\n

There are unique billing and other compliance considerations associated with the use of HUDs. Once approved by HSD, HUD applicants must contact UW Medicine Compliance (206.543.3098; comply@uw.edu<\/a>) to discuss these aspects.<\/p>\n

IRB Requirements for HUDs<\/h2>\n

For clinical use of a HUD<\/strong>, whether emergency or non-emergency and on-label or off-label, see GUIDANCE Humanitarian Use Device, Procedures – Clinical Use of a HUD<\/a>.<\/p>\n

For research use of a HUD<\/strong>, see GUIDANCE Humanitarian Use Device, Procedures – Research Use of a HUD<\/a>.<\/p>\n

 <\/p>\n

<\/a><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Classification Name<\/th>\nGeneric Name<\/th>\nTrade Name<\/th>\nHDE Number<\/th>\nHDE holder<\/th>\n<\/tr>\n
Amnioscope, Transabdominal (Fetoscope) (And Accessories)<\/td>\nAmnioscope, Transabdominal (Fetoscope) (And Accessories)<\/td>\nFetoscopy Instrument Set<\/td>\nH040005<\/td>\nKarl Storz Endoscopy-America, Inc.<\/td>\n<\/tr>\n
Coronary covered stent<\/td>\nCoronary covered stent<\/td>\nPK Papyrus Covered Coronary Stent System<\/td>\nH170004<\/td>\nBiotronik, Inc.<\/td>\n<\/tr>\n
Transcatheter Septal Occluder<\/td>\nTranscatheter Septal Occluder<\/td>\nAMPLATZERTM<\/sup> Post-Infarct Muscular VSD Occluder<\/td>\nH070005<\/td>\nAbbott Medical<\/td>\n<\/tr>\n
Implanted subcortical electrical stimulator (motor disorders)<\/td>\nImplanted subcortical electrical stimulator (motor disorders)<\/td>\nMedtronic Activa Deep Brain Stimulation (DBS) System<\/td>\nH020007<\/td>\nMedtronic Neuromodulation<\/td>\n<\/tr>\n
Intracranial neurovascular stent<\/td>\nIntracranial neurovascular stent<\/td>\nWingspan Stent System with Gateway PTA Balloon Catheter<\/td>\nH050001<\/td>\nStryker Corp.<\/td>\n<\/tr>\n
Deep brain stimulator for obsessive compulsive disorder (OCD)<\/td>\nDeep brain stimulator for obsessive compulsive disorder (OCD)<\/td>\nMetronic (Activa) Deep Brain Stimulation for OCD Therapy<\/td>\nH050003<\/td>\nMedtronic, Neurological Division<\/td>\n<\/tr>\n
Intracranial neurovascular stent<\/td>\nIntracranial neurovascular stent<\/td>\nCodman Enterprise Vascular Reconstructive Device and Delivery System<\/td>\nH060001<\/td>\nCodman & Shurtleff<\/td>\n<\/tr>\n
Cultured epithelial autograft<\/td>\nCultured epithelial autograft<\/td>\nEpicel (cultured epidermal autografts)<\/td>\nH990200<\/td>\nVericel<\/td>\n<\/tr>\n
Intracranial neurovascular stent<\/s><\/td>\nIntracranial neurovascular stent<\/s><\/td>\nNeuroform Microdelivery Stent<\/s><\/td>\nH020002<\/s> PMA approved, 2019<\/td>\nStryker Neurovascular<\/s><\/td>\n<\/tr>\n
Intracranial neurovascular stent<\/s><\/td>\nIntracranial neurovascular stent<\/s><\/td>\nLVIS Intralumijnal Support Device<\/s><\/td>\nH130005<\/s> PMA approved, 2017<\/td>\nMicroVention, Inc<\/s><\/td>\n<\/tr>\n
Right ventricular bypass (assist) device<\/s><\/td>\nRight ventricular bypass (assist) device<\/s><\/td>\nImpella RP System<\/s><\/td>\nH140001<\/s> PMA approved, 2017<\/td>\nAbiomed, Inc<\/s><\/td>\n<\/tr>\n
Microspheres radionuclide<\/s><\/td>\nMicrospheres radionuclide<\/s><\/td>\nMDS Nordion Therasphere Yttrium-90 Glass Microspheres<\/s><\/td>\nH980006<\/s> PMA approval, March 2021<\/td>\nBiocompatibles U.K. Limited<\/s><\/td>\n<\/tr>\n
Intracranial neurovascular stent<\/s><\/td>\nIntracranial neurovascular stent<\/s><\/td>\nPulseRider Aneurysm Neck Reconstruction Device<\/s><\/td>\nH160002<\/s>Device was discontinued on October 31, 2023<\/td>\nPulsar Vascular<\/s><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

The Humanitarian Use Devices (HUDs) listed in this table have all been approved by the UW IRB for clinical use at UW Medicine. HSD does its…<\/p>\n","protected":false},"author":158,"featured_media":0,"parent":43384,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-23005","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nUW IRB Approved Clinical Use HUDs - UW Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UW IRB Approved Clinical Use HUDs - UW Research\" \/>\n<meta property=\"og:description\" content=\"The Humanitarian Use Devices (HUDs) listed in this table have all been approved by the UW IRB for clinical use at UW Medicine. HSD does its...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/\" \/>\n<meta property=\"og:site_name\" content=\"UW Research\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-19T21:51:44+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/\",\"url\":\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/\",\"name\":\"UW IRB Approved Clinical Use HUDs - UW Research\",\"isPartOf\":{\"@id\":\"https:\/\/www.washington.edu\/research\/#website\"},\"datePublished\":\"2018-04-19T18:45:04+00:00\",\"dateModified\":\"2025-11-19T21:51:44+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.washington.edu\/research\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Human Subjects Division\",\"item\":\"https:\/\/www.washington.edu\/research\/hsd\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Topic-Based Guidance\",\"item\":\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"Humanitarian Use Device Guidance\",\"item\":\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/\"},{\"@type\":\"ListItem\",\"position\":5,\"name\":\"UW IRB Approved Clinical Use HUDs\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.washington.edu\/research\/#website\",\"url\":\"https:\/\/www.washington.edu\/research\/\",\"name\":\"UW Research\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.washington.edu\/research\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"UW IRB Approved Clinical Use HUDs - UW Research","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/","og_locale":"en_US","og_type":"article","og_title":"UW IRB Approved Clinical Use HUDs - UW Research","og_description":"The Humanitarian Use Devices (HUDs) listed in this table have all been approved by the UW IRB for clinical use at UW Medicine. HSD does its...","og_url":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/","og_site_name":"UW Research","article_modified_time":"2025-11-19T21:51:44+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/","url":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/","name":"UW IRB Approved Clinical Use HUDs - UW Research","isPartOf":{"@id":"https:\/\/www.washington.edu\/research\/#website"},"datePublished":"2018-04-19T18:45:04+00:00","dateModified":"2025-11-19T21:51:44+00:00","breadcrumb":{"@id":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/approved-huds\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.washington.edu\/research\/"},{"@type":"ListItem","position":2,"name":"Human Subjects Division","item":"https:\/\/www.washington.edu\/research\/hsd\/"},{"@type":"ListItem","position":3,"name":"Topic-Based Guidance","item":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/"},{"@type":"ListItem","position":4,"name":"Humanitarian Use Device Guidance","item":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/"},{"@type":"ListItem","position":5,"name":"UW IRB Approved Clinical Use HUDs"}]},{"@type":"WebSite","@id":"https:\/\/www.washington.edu\/research\/#website","url":"https:\/\/www.washington.edu\/research\/","name":"UW Research","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.washington.edu\/research\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/pages\/23005","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/users\/158"}],"replies":[{"embeddable":true,"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/comments?post=23005"}],"version-history":[{"count":29,"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/pages\/23005\/revisions"}],"predecessor-version":[{"id":60588,"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/pages\/23005\/revisions\/60588"}],"up":[{"embeddable":true,"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/pages\/43384"}],"wp:attachment":[{"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/media?parent=23005"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}