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
1393–1416 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 29, 2018
Servator B SALF Solution
K180481 · KDN
S.A.L.F. Spa
Gastroenterology & Urology · 126d
Cleared Jun 29, 2018
Ensizor Monopolar Endoscopic Scissors
K180134 · KGE
Slater Endoscopy, LLC
Gastroenterology & Urology · 163d
Cleared Jun 29, 2018
Ecolab POU Water Filter
K173164 · NHV
Ecolab, Inc.
Gastroenterology & Urology · 273d
Cleared Jun 29, 2018
TubeClear System
K172556 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 309d
Cleared Jun 28, 2018
Angled Tip Ureteral Catheter
K181144 · KOD
Cook Incorporated
Gastroenterology & Urology · 58d
Cleared Jun 28, 2018
LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
K180583 · FET
Richard Wolf Medical Instruments...
Gastroenterology & Urology · 115d
Cleared Jun 28, 2018
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable...
K173162 · PWJ
Ethicon, Inc.
Gastroenterology & Urology · 272d
Cleared Jun 27, 2018
OverStitch Endoscopic Suturing System and Accessories
K181141 · OCW
Apollo Endosurgery
Gastroenterology & Urology · 57d
Cleared Jun 22, 2018
VaPro 2 Intermittent Catheter
K180824 · GBM
Hollister Incorporated
Gastroenterology & Urology · 84d
Cleared Jun 22, 2018
Advance Biliary Balloon Catheter
K173414 · GCA
Cook Incorporated
Gastroenterology & Urology · 233d
Cleared Jun 22, 2018
Perfadex Plus
K170826 · KDN
Xvivo Perfusion AB
Gastroenterology & Urology · 459d
Cleared Jun 21, 2018
Pure Vu System
K181437 · FDF
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 20d
Cleared Jun 20, 2018
Swiss LithoClast Trilogy
K181364 · FEO
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 28d
Cleared Jun 19, 2018
SpeedBird Model SB38 Soft Tissue Biopsy Device
K173316 · KNW
Transmed7, LLC
Gastroenterology & Urology · 243d
Cleared Jun 14, 2018
COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent...
K180738 · EZD
Compactcath, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 14, 2018
Ligation Device
K172985 · FHN
Leo Medical Co., Ltd.
Gastroenterology & Urology · 260d
Cleared Jun 08, 2018
Single Use Aspiration Needle NA-U200H
K180449 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 108d
Cleared Jun 07, 2018
FOCAL ONE
K172721 · PLP
Edap Technomed, Inc.
Gastroenterology & Urology · 272d
Cleared Jun 04, 2018
Silicone Foley Catheter for single use
K172807 · EZL
Changzhou Rongxin Medicine Minimal...
Gastroenterology & Urology · 259d
Cleared Jun 01, 2018
Colonic Plus Regular, Small, and Straight Shape Hydrokit
K180800 · KPL
Colonic Plus
Gastroenterology & Urology · 66d
Cleared Jun 01, 2018
Single Use MultiClip Device
K180325 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 116d
Cleared Jun 01, 2018
Bowel Management Device, Bowel Management Irrigation Set
K180026 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 149d
Cleared May 25, 2018
FUJIFILM Endoscopic CO2 Regulator GW-100
K180711 · FCX
Fujifilm Corporation
Gastroenterology & Urology · 67d
Cleared May 25, 2018
ClearGuard HD Antimicrobial Barrier Cap
K180111 · PEH
Pursuit Vascular, Inc.
Gastroenterology & Urology · 129d