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
769–792 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 23, 2022
CORE-CLIP
K213338 · PKL
Incore Co., Ltd.
Gastroenterology & Urology · 259d
Cleared Jun 22, 2022
Esophageal TTS Stent
K221482 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 30d
Cleared Jun 22, 2022
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
K213283 · GBM
Convatec Limited
Gastroenterology & Urology · 264d
Cleared Jun 17, 2022
Disposable Endoscopy Adapter Set
K220210 · ODC
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 142d
Cleared Jun 14, 2022
BEL-GEN Cold Storage Solution
K221387 · KDL
Institut Georges Lopez
Gastroenterology & Urology · 32d
Cleared Jun 14, 2022
PERF-GEN Pulsatile Perfusion Solution
K221386 · KDL
Institut Georges Lopez
Gastroenterology & Urology · 32d
Cleared Jun 13, 2022
Disposable Hemostatic Closure Clip Device
K220157 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 145d
Not Cleared Jun 13, 2022
ProdiGI
DEN220006 · QSW
Covidien, LLC
Gastroenterology & Urology · 150d
Cleared Jun 09, 2022
Niti-S Biliary Slim M Stent
K221071 · FGE
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 58d
Cleared Jun 09, 2022
Nasogastric Feeding Tubes - ENFit Port - PVC
K213258 · PIF
Cair Lgl
Gastroenterology & Urology · 252d
Cleared Jun 09, 2022
Cysto-Gastro-Sets
K211909 · KNS
G-Flex Europe Sprl
Gastroenterology & Urology · 353d
Cleared Jun 08, 2022
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone...
K213185 · FAD
Coloplast Corp.
Gastroenterology & Urology · 252d
Cleared Jun 07, 2022
Lap-Band System Calibration Tube
K220455 · KNT
Reshape Lifesciences
Gastroenterology & Urology · 110d
Cleared Jun 06, 2022
Multi-Band Ligator
K213223 · FHN
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 250d
Cleared Jun 06, 2022
Disposable Polypectomy Snare
K213222 · FDI
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 250d
Cleared Jun 03, 2022
Gastric Alimetry System
K213924 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 170d
Cleared Jun 02, 2022
Endoscopic Injection Needle
K213239 · FBK
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 245d
Cleared Jun 01, 2022
FROG Forceps Valve (VAL1-F1-100)
K221264 · ODC
Fujifilm Medwork GmbH
Gastroenterology & Urology · 30d
Cleared May 27, 2022
MoistureMeterD Compact, LymphScanner
K220557 · OBH
Delfin Technologies, Ltd.
Gastroenterology & Urology · 88d
Cleared May 27, 2022
Single Use Hemoclip
K212669 · PKL
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 277d
Cleared May 25, 2022
Single Use Ureteral Access Sheath
K220065 · FED
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 135d
Cleared May 19, 2022
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
K213174 · PIF
Cardinalhealth
Gastroenterology & Urology · 233d
Cleared May 19, 2022
RevoLix HTL
K211534 · GEX
Lisa Laser Products GmbH
Gastroenterology & Urology · 366d
Cleared May 18, 2022
Siren SGT
K220218 · KNT
Tools For Surgery, LLC
Gastroenterology & Urology · 112d