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
5497–5520 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 25, 1995
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM
K952563 · GCT
The Tulip Mfg. Co.
Gastroenterology & Urology · 53d
Cleared Jul 25, 1995
XENON LIGHT SOURCE MODEL 5121
K952696 · GCT
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 42d
Cleared Jul 21, 1995
EPX-310 VIDEO PROCESSOR (ENDOSCOPY)
K950417 · FET
Marks & Murase
Gastroenterology & Urology · 171d
Cleared Jul 21, 1995
CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC...
K951972 · FBO
Cabot Medical Corp.
Gastroenterology & Urology · 85d
Cleared Jul 20, 1995
GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY
K923488 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 1100d
Cleared Jul 20, 1995
KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES,...
K952574 · FJL
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 45d
Cleared Jul 19, 1995
METAL URETERAL BASKET STONE DISLODGER
K951532 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 107d
Cleared Jul 19, 1995
XXL BALLOON DILATATION CATHETER
K952656 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 72d
Cleared Jul 19, 1995
FORCEPS, BIOPSY, NON-ELECTRIC
K952863 · FCL
Annex Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Jul 18, 1995
POWER RESECTOSCOPE CUTTING LOOP
K951897 · FAS
Power Analytics Corp.
Gastroenterology & Urology · 85d
Cleared Jul 18, 1995
ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER
K952082 · EXJ
Rochester Medical Corp.
Gastroenterology & Urology · 76d
Cleared Jul 14, 1995
TE-800 PELVIC FLOOR EXERCISER
K945937 · HIR
Myo/Kinetic Systems, Inc.
Gastroenterology & Urology · 221d
Cleared Jul 06, 1995
CLEAR ADVANTAGE II
K945628 · EXJ
Mentor Corp.
Gastroenterology & Urology · 232d
Cleared Jul 06, 1995
AMS 650 MALLERABLE PENIEL PROSTHESIS
K951716 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 83d
Cleared Jul 06, 1995
PIPER, MODEL NUMBER UDS-PIPERB
K951805 · FEN
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 79d
Cleared Jul 05, 1995
EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
K951533 · KDH
Ballard Medical Products
Gastroenterology & Urology · 93d
Cleared Jun 30, 1995
GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES
K941973 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 434d
Cleared Jun 29, 1995
EUROPHILIC SLIPPERY COATED FOLEY CATHETER
K944007 · EZL
Baxter Healthcare Corp
Gastroenterology & Urology · 317d
Cleared Jun 29, 1995
FS-34P2, FIBER SIGMOIDOSCOPE
K951576 · FAM
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 86d
Cleared Jun 27, 1995
FS-38X, FIBER SIGMOIDOSCOPE
K951572 · FAM
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 84d
Cleared Jun 27, 1995
FS-38H, FIBER SIGMOIDOSCOPE
K951573 · FAM
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 84d
Cleared Jun 27, 1995
FC-38TLH, FIBER COLONOSCOPE
K951575 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 84d
Cleared Jun 27, 1995
FC-38LX, FIBER COLONOSCOPE
K951578 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 84d
Cleared Jun 27, 1995
FC-38LH, FIBER COLONOSCCOPE
K951580 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 84d