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
2329–2352 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 11, 2012
ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
K120766 · FAJ
Prosurg, Inc.
Gastroenterology & Urology · 182d
Cleared Sep 11, 2012
ROTH NET RETRIEVER
K122462 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 10, 2012
BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
K120126 · FED
Barosense, Inc.
Gastroenterology & Urology · 237d
Cleared Sep 07, 2012
MINIARC PRO SINGLE-INCISION SLING SYSTEM
K121641 · PAH
American Medical Systems
Gastroenterology & Urology · 95d
Cleared Sep 06, 2012
PADLOCK CLIP-12
K120814 · PKL
Aponos Medical Corp.
Gastroenterology & Urology · 171d
Cleared Sep 05, 2012
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL...
K121383 · FJS
Medical Components, Inc.
Gastroenterology & Urology · 120d
Cleared Sep 05, 2012
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
K122030 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 56d
Cleared Sep 04, 2012
ARC ENDOCUFF
K122565 · FED
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 13d
Cleared Aug 31, 2012
DISPOSABLE HEMOSTASIS CHIP
K121505 · PKL
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 102d
Cleared Aug 27, 2012
BAROSTAT SOFTWARE OPTION
K120997 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 147d
Cleared Aug 24, 2012
INWAVE
K121820 · KPI
Zynex Medical, Inc.
Gastroenterology & Urology · 64d
Cleared Aug 22, 2012
SWANNSHIDI BONE MARROW ASPIRATION NEEDLE
K121181 · KNW
Alliance Partners, LLC
Gastroenterology & Urology · 126d
Cleared Aug 21, 2012
SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC...
K111627 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 438d
Cleared Aug 21, 2012
ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI...
K113062 · FBP
Endoservice Optical Instruments GmbH
Gastroenterology & Urology · 312d
Cleared Aug 17, 2012
VENOFER PUMP
K121497 · KDI
Renal Solutions, Inc.
Gastroenterology & Urology · 88d
Cleared Aug 17, 2012
TRUETOME
K122203 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 23d
Cleared Aug 09, 2012
XENX
K113692 · OCY
Xenolith Medical
Gastroenterology & Urology · 238d
Cleared Aug 03, 2012
UROPLASTY RIGID ENDOSCPIC NEEDLES
K121337 · FBK
Uroplasty, Inc.
Gastroenterology & Urology · 92d
Cleared Aug 01, 2012
SOLAR GI
K121014 · FFX
Medical Measurement Systems B.V.
Gastroenterology & Urology · 120d
Cleared Jul 27, 2012
ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
K121604 · FER
Obp Corporation
Gastroenterology & Urology · 56d
Cleared Jul 26, 2012
FUJINON COLONOSCOPES
K112391 · FDF
Fujinon, Inc.
Gastroenterology & Urology · 342d
Cleared Jul 26, 2012
WI-FI BODY SCALE
K120896 · MNW
Andon Health Co, Ltd.
Gastroenterology & Urology · 122d
Cleared Jul 17, 2012
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
K121832 · FGE
Merit Medical Systems, Inc.
Gastroenterology & Urology · 25d
Cleared Jul 16, 2012
OSTOMY IRRIGATION SET
K121833 · EXD
Coloplast A/S
Gastroenterology & Urology · 24d