FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Gastroenterology & Urology ×
9,870 results
841–864 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 20, 2022
Flexible Video-Uretero-Renoscope SSU System
K212458 · FGB
Karl Storz Endoscopy America
Gastroenterology & Urology · 168d
Cleared Jan 20, 2022
KIDNEY ASSIST-transport
K211333 · KDN
Xvivo Perfusion AB
Gastroenterology & Urology · 262d
Cleared Jan 14, 2022
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis...
K213602 · FJS
Covidien, LLC
Gastroenterology & Urology · 60d
Cleared Jan 14, 2022
Wellead Endoscopic Seal
K211814 · ODC
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 217d
Cleared Jan 12, 2022
andorate Suction Valve, andorate Air/Water Valve
K213095 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 110d
Cleared Jan 10, 2022
G-Tech Wireless Patch System (WPS)
K212954 · MYE
G-Tech Medical
Gastroenterology & Urology · 116d
Cleared Dec 21, 2021
CT3000Pro
K212830 · FEN
Srs Medical
Gastroenterology & Urology · 105d
Cleared Dec 20, 2021
AdVance XP Male Sling System
K211847 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 188d
Cleared Dec 20, 2021
Servator M SALF Solution
K211842 · KDL
S.A.L.F. Spa
Gastroenterology & Urology · 188d
Cleared Dec 17, 2021
RF Vapor System
K213627 · KNS
Aqua Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 14, 2021
Aspira Peritoneal Drainage System
K212675 · PNG
Merit Medical Systems, Inc.
Gastroenterology & Urology · 112d
Cleared Dec 07, 2021
endomina system
K211309 · OCW
Endo Tools Therapeutics S.A.
Gastroenterology & Urology · 221d
Cleared Dec 06, 2021
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM)...
K212852 · ODG
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 03, 2021
Everyway Incontinence Stimulation System
K213116 · KPI
Everyway Medical Instruments Co.,Ltd
Gastroenterology & Urology · 67d
Cleared Dec 01, 2021
Sphincterotome / short-wire compatible, Sterile Sphincterotome
K210934 · KNS
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 247d
Cleared Nov 26, 2021
Tablo Cartridge
K210782 · FJK
Outset Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Nov 24, 2021
Regulora
K211463 · QMY
Metame Health, Inc.
Gastroenterology & Urology · 197d
Cleared Nov 23, 2021
Exablate Prostate System
K212150 · PLP
InSightec, Inc.
Gastroenterology & Urology · 137d
Cleared Nov 23, 2021
Uretero1 Ureteroscope System
K211347 · FGB
STERIS Corporation
Gastroenterology & Urology · 204d
Not Cleared Nov 23, 2021
vPatch
DEN210012 · QRC
Virility Medical
Gastroenterology & Urology · 238d
Cleared Nov 22, 2021
Agile Esophageal OTW Stent System
K211960 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 151d
Cleared Nov 19, 2021
EndoScreener
K211326 · QNP
Chengdu Wision Medical Device Co., Ltd.
Gastroenterology & Urology · 203d
Cleared Nov 19, 2021
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
K211032 · KOD
Urogen Pharma, Ltd.
Gastroenterology & Urology · 226d
Cleared Nov 18, 2021
HANAROSTENT Esophagus Asymmetric (CCC)
K213251 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 49d