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
4705–4728 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 03, 1998
VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER
K981994 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 87d
Cleared Sep 02, 1998
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K982005 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 86d
Cleared Aug 28, 1998
POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)
K981011 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 163d
Cleared Aug 28, 1998
REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING...
K981180 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 149d
Cleared Aug 27, 1998
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
K974090 · MSE
Fresenius Medical Care North America
Gastroenterology & Urology · 302d
Cleared Aug 26, 1998
HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER,...
K982378 · KPO
Solution Technologies
Gastroenterology & Urology · 49d
Cleared Aug 20, 1998
URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100,...
K982626 · EZL
Medworks Corp.
Gastroenterology & Urology · 23d
Cleared Aug 19, 1998
FUTREX-6100/XL
K963271 · MNW
Futrex, Inc.
Gastroenterology & Urology · 729d
Cleared Aug 19, 1998
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
K982289 · KNS
Olympus America, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 17, 1998
A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE
K971434 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 486d
Cleared Aug 11, 1998
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K981681 · KDI
Gambro Healthcare
Gastroenterology & Urology · 90d
Cleared Aug 11, 1998
DEROYAL INDUSTRIES, INC. DEFOGGER
K982465 · OCT
Deroyal Industries, Inc.
Gastroenterology & Urology · 27d
Cleared Aug 06, 1998
GC IRRIGATOR
K980868 · KPL
Gentle Colonics, Inc.
Gastroenterology & Urology · 153d
Cleared Aug 05, 1998
LIGHT SABER CORE TISSUE NEEDLE
K981796 · KNW
Minrad, Inc.
Gastroenterology & Urology · 76d
Cleared Jul 31, 1998
WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
K981889 · FCG
Worldwide Medical Technologies, LLC
Gastroenterology & Urology · 63d
Cleared Jul 30, 1998
SNAP-N-PEEL INTRODUCERS
K981611 · KNY
Circon Corp.
Gastroenterology & Urology · 85d
Cleared Jul 29, 1998
MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)
K981856 · FET
Greatbatch Scientific
Gastroenterology & Urology · 63d
Cleared Jul 28, 1998
C0-AXIAL INTRODUCER NEEDLE
K981721 · KNW
Inrad
Gastroenterology & Urology · 74d
Cleared Jul 28, 1998
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
K981827 · FET
Angiolaz, Inc.
Gastroenterology & Urology · 67d
Cleared Jul 24, 1998
XENON LIGHT SOURCE MODEL LS6000
K981804 · GCT
Contec Medical Vision, Ltd.
Gastroenterology & Urology · 64d
Cleared Jul 23, 1998
ALTRA FLUX 200 HEMODIALYZER
K970679 · MSF
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 514d
Cleared Jul 23, 1998
ALTRA NOVA 200 HEMODIALYZER
K970681 · MSF
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 514d
Cleared Jul 21, 1998
ITI STENT
K980290 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 176d
Cleared Jul 17, 1998
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY...
K982085 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 32d