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
4849–4872 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 21, 1998
MICROVASIVE LIPTHOTRIPSY PROBES
K973788 · FFK
Boston Scientific Corp
Gastroenterology & Urology · 107d
Cleared Jan 21, 1998
REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE,...
K974312 · KNW
Telemed Systems, Inc.
Gastroenterology & Urology · 65d
Cleared Jan 20, 1998
WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
K974018 · FHN
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 13, 1998
SILICONE ANTIBACTERIAL FOLEY CATHETER
K971627 · MJC
Rochester Medical Corp.
Gastroenterology & Urology · 256d
Cleared Jan 12, 1998
LAPAROSCOPIC GASTROSTOMY KIT
K973891 · KNT
Applied Medical Resources
Gastroenterology & Urology · 90d
Cleared Jan 11, 1998
CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)
K970663 · MSF
Baxter Healthcare Corp
Gastroenterology & Urology · 324d
Cleared Jan 09, 1998
GALLINI ABS DEVICE
K973152 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 140d
Cleared Jan 09, 1998
MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION...
K973584 · ESW
Medtech Instruments
Gastroenterology & Urology · 109d
Cleared Jan 09, 1998
WINGED NEEDLE HOLDER
K974327 · FHQ
Phx Technologies Corp.
Gastroenterology & Urology · 52d
Cleared Jan 09, 1998
VTU-E VACUUM ERECTION SYSTEM
K974470 · LKY
Encore, Inc.
Gastroenterology & Urology · 44d
Cleared Jan 09, 1998
MANAN(TM) SUPER-CORE BIOPSY NEEDLES
K974814 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 09, 1998
MANAN(TM) INTRODUCER SHEATH/NEEDLE
K974815 · FGE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 09, 1998
MANAN GENERAL PURPOSE INTRODUCER NEEDLE
K980004 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 7d
Cleared Jan 08, 1998
HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18,...
K971442 · KPN
Humed, Inc.
Gastroenterology & Urology · 262d
Cleared Jan 08, 1998
RUSCH BRILLANT SILICONE FOLEY CATHETER
K972184 · EZL
Rusch Intl.
Gastroenterology & Urology · 212d
Cleared Jan 08, 1998
MANAN AUTOMATIC CUTTING NEEDLE
K974446 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 44d
Cleared Jan 08, 1998
MANAN TECHNA-CUT ASPIRATION NEEDLE
K974766 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 07, 1998
ELECTRODES/PROBES/DEVICES
K974637 · FAS
Ximed/Prosure/Injectx
Gastroenterology & Urology · 26d
Cleared Jan 05, 1998
PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
K970648 · MSF
Renal Systems, Inc.
Gastroenterology & Urology · 319d
Cleared Dec 23, 1997
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K974048 · KPI
Hollister, Inc.
Gastroenterology & Urology · 60d
Cleared Dec 22, 1997
PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
K974036 · HIR
The Prometheus Group
Gastroenterology & Urology · 59d
Cleared Dec 22, 1997
ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
K974515 · FAS
Endolap, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 22, 1997
ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
K974516 · FAS
Endolap, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 19, 1997
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
K970708 · FJI
Terumo Medical Corp.
Gastroenterology & Urology · 296d