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
1465–1488 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 12, 2018
RocaJJ Soft Stents
K173734 · FAD
Promepla Sam
Gastroenterology & Urology · 96d
Cleared Mar 09, 2018
VORTEK URETERAL DOUBLE LOOP STENT
K180057 · FAD
Coloplast Corp.
Gastroenterology & Urology · 60d
Cleared Mar 09, 2018
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets,...
K172057 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 246d
Cleared Mar 08, 2018
PillCam Patency System
K180171 · NSI
Given Imaging , Ltd.
Gastroenterology & Urology · 45d
Cleared Mar 08, 2018
THD Anopress with THD SensyProbe
K180135 · KLA
Thd Spa
Gastroenterology & Urology · 50d
Cleared Mar 08, 2018
Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
K180086 · FGE
Gyrus Acmi, Inc.
Gastroenterology & Urology · 55d
Cleared Mar 07, 2018
Rotatable Snares, Non-Rotatable Snares
K172758 · FDI
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 175d
Cleared Mar 07, 2018
Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
K171810 · KOD
Cook Incorporated
Gastroenterology & Urology · 261d
Cleared Mar 06, 2018
Citric Complete Dry Citric Acid (45X)
K171750 · KPO
Dimesol USA, LLC
Gastroenterology & Urology · 266d
Cleared Mar 05, 2018
Cytology Brush
K172663 · FDX
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 181d
Cleared Mar 02, 2018
Spectra Optia Apheresis System
K172590 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 185d
Cleared Mar 01, 2018
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and...
K172916 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 157d
Cleared Mar 01, 2018
Nathanson Transcystic Bile Duct Stone Exploration Pack
K171915 · LQR
Cook Incorporated
Gastroenterology & Urology · 248d
Cleared Feb 27, 2018
Rezum System
K180237 · KNS
Nxthera, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 27, 2018
Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex...
K172044 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 236d
Cleared Feb 26, 2018
Stryker iVAS 13g Bone Biopsy Kit
K180327 · KNW
Stryker Corporation
Gastroenterology & Urology · 20d
Cleared Feb 26, 2018
OpClear System
K171637 · OCX
Cipher Surgical, Ltd.
Gastroenterology & Urology · 269d
Cleared Feb 23, 2018
Prismaflex System 8.10
K171671 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 262d
Cleared Feb 23, 2018
Ultraxx Nephrostomy Balloon Catheter
K171601 · LJE
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared Feb 22, 2018
Medline Catheter Specimen Collector
K172541 · EZD
Medline Industries, Inc.
Gastroenterology & Urology · 183d
Cleared Feb 16, 2018
Renal Access Cobra Catheter, Kumpe Access Catheter
K171600 · KOD
Cook Incorporated
Gastroenterology & Urology · 260d
Cleared Feb 14, 2018
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
K173651 · KDJ
Fresenius Medical Care Renal...
Gastroenterology & Urology · 78d
Cleared Feb 12, 2018
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775 · OCW
Teleflexmedical, Inc.
Gastroenterology & Urology · 151d
Cleared Feb 09, 2018
ORISE Tissue Retractor System
K173400 · FED
Boston Scientific
Gastroenterology & Urology · 101d