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
2737–2760 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 30, 2009
SMARTPILL GI MONITORING SYSTEM, VERSION 2.0
K092342 · NYV
The Smartpill Corporation
Gastroenterology & Urology · 87d
Cleared Oct 23, 2009
CLEARPATH
K091305 · FDF
Easyglide , Ltd.
Gastroenterology & Urology · 172d
Cleared Oct 23, 2009
ENTRACARE GASTROSTOMY FEEDING TUBE
K092418 · KNT
Entracare, LLC
Gastroenterology & Urology · 78d
Cleared Oct 20, 2009
COLONIC SPLINTING OVERTUBE, MODEL 00711145
K092221 · FED
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 16, 2009
WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
K091516 · EZL
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 147d
Cleared Oct 14, 2009
ELECTROFLUIDGRAPH
K091369 · MNW
Akern USA, LLC
Gastroenterology & Urology · 159d
Cleared Oct 14, 2009
CAD 12, COLONOSCOPY ASSIST DEVICE
K092156 · FED
Softscope Medical Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 09, 2009
3 WAY SILICONE FOLEY BALLOON CATHETER
K091767 · EZL
Cook Urological, Inc.
Gastroenterology & Urology · 114d
Cleared Oct 09, 2009
IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT
K092049 · KNT
Sainath Intellectual Properties, LLC
Gastroenterology & Urology · 94d
Cleared Oct 08, 2009
BODY COMPOSITION ANALYZER, MODEL: IOI 353
K092431 · MNW
Jawon Medical Co., Ltd.
Gastroenterology & Urology · 62d
Cleared Sep 30, 2009
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER
K091962 · ODF
Lumenis, Inc.
Gastroenterology & Urology · 91d
Cleared Sep 29, 2009
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
K091637 · KNT
Corpak Medsystems
Gastroenterology & Urology · 117d
Cleared Sep 28, 2009
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
K083840 · GCM
Msi Medserv International Deutschland...
Gastroenterology & Urology · 278d
Cleared Sep 28, 2009
GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE...
K090557 · NSI
Given Imaging , Ltd.
Gastroenterology & Urology · 210d
Cleared Sep 25, 2009
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
K090183 · KNQ
Cook Endoscopy
Gastroenterology & Urology · 242d
Cleared Sep 24, 2009
RP CUTTING NEEDLE
K092059 · KNW
Riverpoint Medical
Gastroenterology & Urology · 79d
Cleared Sep 18, 2009
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND...
K091759 · KNT
Olympus Medical Systems Corporation
Gastroenterology & Urology · 94d
Cleared Sep 15, 2009
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
K081996 · FGE
Flexible Stenting Solutions, Inc.
Gastroenterology & Urology · 428d
Cleared Sep 14, 2009
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
K091968 · FCW
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Sep 03, 2009
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V...
K091495 · LQR
Olympus Medical Systems Corporation
Gastroenterology & Urology · 106d
Cleared Aug 25, 2009
DIRECTVISION GUIDE SYSTEM
K091600 · FGC
Percuvision, LLC
Gastroenterology & Urology · 83d
Cleared Aug 21, 2009
AMSURE PVC INTERMITTENT CATHETER
K091306 · EZD
Amsino International, Inc.
Gastroenterology & Urology · 109d
Cleared Aug 20, 2009
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064,...
K090960 · GBM
Hollister, Inc.
Gastroenterology & Urology · 136d
Cleared Aug 12, 2009
FOOTPRINT URINARY DRAINAGE CATHETER
K090576 · EZD
Footprint Medical
Gastroenterology & Urology · 162d