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
865–888 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 17, 2021
Qora Stool Management Kit
K212444 · KNT
Cm Technologies, Inc.
Gastroenterology & Urology · 104d
Cleared Nov 16, 2021
Enteral Feeding Set
K210854 · PIF
Kb Medical (Group), Inc.
Gastroenterology & Urology · 238d
Cleared Nov 10, 2021
Disposable Automatic Core Biopsy Instrument
K212284 · KNW
Suzhou Leapmed Healthcare Corporation
Gastroenterology & Urology · 112d
Cleared Nov 10, 2021
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7...
K211975 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 138d
Cleared Nov 03, 2021
FLUME catheter
K212151 · EZL
The Flume Catheter Company, Ltd.
Gastroenterology & Urology · 117d
Cleared Nov 02, 2021
Pediatric Nasogastric Feeding Tubes - Single ENFit Port
K210598 · PIF
Cair Lgl
Gastroenterology & Urology · 246d
Cleared Oct 29, 2021
Balloon BS-3
K213195 · FDA
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Oct 22, 2021
DiLumen C2 and Tool Mount
K211819 · FDF
Lumendi, LLC
Gastroenterology & Urology · 133d
Cleared Oct 20, 2021
Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic...
K210618 · OCX
Chongqing Jinshan Science &...
Gastroenterology & Urology · 233d
Cleared Oct 20, 2021
PENTAX Medical Video Upper GI Scopes EG17-J10
K210177 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 271d
Cleared Oct 19, 2021
U9000 Plus Ultrafilter
K211035 · FIP
Baxter Healthcare Corporation
Gastroenterology & Urology · 195d
Cleared Oct 15, 2021
RM4 Control Unit
K211224 · KDN
Institut Georges Lopez
Gastroenterology & Urology · 175d
Cleared Oct 08, 2021
Esophageal TTS Stent
K211706 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 127d
Cleared Oct 07, 2021
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack...
K212860 · FDI
STERIS Corporation
Gastroenterology & Urology · 29d
Cleared Oct 06, 2021
AquaBeam Robotic System
K212835 · PZP
Procept Biorobotics, Corporation
Gastroenterology & Urology · 29d
Cleared Oct 05, 2021
Bipolar Coagulation Foreceps
K210406 · KGE
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 237d
Cleared Oct 01, 2021
PENTAX Medical Auto Leakage Tester SHA-P6
K212201 · PCV
Pentax of America, Inc.
Gastroenterology & Urology · 79d
Cleared Oct 01, 2021
D Camera Controller
K211332 · FET
Richard Wolf Medical Instruments...
Gastroenterology & Urology · 151d
Cleared Sep 30, 2021
Enteral Pump Syringe
K211593 · PNR
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology · 129d
Cleared Sep 29, 2021
ENDOtube
K203350 · OCX
Nissha Medical Technologies Sas
Gastroenterology & Urology · 320d
Cleared Sep 23, 2021
Standard Bougie, 38 Fr. and Hand Pump
K212728 · KNT
Standard Bariatrics
Gastroenterology & Urology · 27d
Cleared Sep 21, 2021
Flyte
K212655 · HIR
Pelvital USA, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 20, 2021
CT-STOR
K201789 · NDS
Energy Delivery Solutions
Gastroenterology & Urology · 447d
Cleared Sep 17, 2021
Incontinence Probe
K210441 · KPI
Shenzhen Med-Link Electronics Tech...
Gastroenterology & Urology · 217d