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
5569–5592 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 12, 1995
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND...
K945907 · FGC
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 161d
Cleared May 12, 1995
PROSYS URIHESIVE SYSTEM LA
K951530 · EXJ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 39d
Cleared May 12, 1995
MIST ENDOSCOPIC NEEDLES
K951648 · FBK
Mist, Inc.
Gastroenterology & Urology · 32d
Cleared May 11, 1995
THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE
K932149 · HIR
Thought Technology , Ltd.
Gastroenterology & Urology · 737d
Cleared May 11, 1995
INCONTROL
K935213 · HIR
Thought Technology , Ltd.
Gastroenterology & Urology · 559d
Cleared May 11, 1995
FST FIBEROPTIC PRESSURE CONVERTER
K945753 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 169d
Cleared May 11, 1995
KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR...
K950974 · FET
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 70d
Cleared May 11, 1995
KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR)...
K950975 · FET
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 70d
Cleared May 11, 1995
METEL URETERAL BASKET STONE DISLODGER
K951761 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 24d
Cleared May 04, 1995
FILTRYZER
K940910 · FJI
Toray Industries (America), Inc.
Gastroenterology & Urology · 433d
Cleared May 03, 1995
JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT
K925469 · FKG
J.J. Skinner, Inc.
Gastroenterology & Urology · 916d
Cleared May 03, 1995
BAXTER BIOSTAT 1000 UREA MONITOR
K925581 · KXM
Baxter Healthcare Corp
Gastroenterology & Urology · 909d
Cleared May 03, 1995
CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)
K945185 · FBO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 191d
Cleared May 03, 1995
ENDOSCOPIC ACCESSORY
K945191 · FAS
Un-I-Med, Inc.
Gastroenterology & Urology · 191d
Cleared May 03, 1995
DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
K950784 · EYQ
Advanced Bioresearch Assoc.
Gastroenterology & Urology · 71d
Cleared May 03, 1995
OLYMPUS FD-5 HOT BIOPSY FORCEPS
K951445 · KGE
Olympus America, Inc.
Gastroenterology & Urology · 35d
Cleared Apr 28, 1995
MD400 A/B/C/D/E/F/G
K944385 · FIP
International Purification Systems, Inc.
Gastroenterology & Urology · 233d
Cleared Apr 28, 1995
SILASTIC BRAND FOLEY CATHETER
K951103 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 49d
Cleared Apr 27, 1995
SERIES 400 GASTROENTEROLOGY SYSTEM
K944620 · FET
Marks & Murase
Gastroenterology & Urology · 219d
Cleared Apr 27, 1995
BARD FLEXIBLE TIP URETERAL CATHETER
K950300 · EYB
C.R. Bard, Inc.
Gastroenterology & Urology · 92d
Cleared Apr 27, 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950454 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 83d
Cleared Apr 27, 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950522 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 80d
Cleared Apr 27, 1995
BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
K950700 · ODD
C.R. Bard, Inc.
Gastroenterology & Urology · 71d
Cleared Apr 25, 1995
KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
K951488 · KNY
The Kendal Co.
Gastroenterology & Urology · 25d