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
6073–6096 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 18, 1993
STAND ALONE CYSTOMETROGRAM
K934141 · FEN
Medical Engineering Corp.
Gastroenterology & Urology · 85d
Cleared Nov 17, 1993
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K930456 · KNT
Interventional Therapeutics Corp.
Gastroenterology & Urology · 294d
Cleared Nov 17, 1993
DILATING URETHRAL SOUND
K933957 · FAH
Cook Urological, Inc.
Gastroenterology & Urology · 97d
Cleared Nov 16, 1993
MENLO CARE AQUASTENT SET
K923394 · FAD
Menlo Care, Inc.
Gastroenterology & Urology · 494d
Cleared Nov 15, 1993
DISPOSABLE PENILE BLOOD PRESSURE CUFFS
K932851 · DXQ
D. E. Hokanson, Inc.
Gastroenterology & Urology · 158d
Cleared Nov 15, 1993
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR
K933400 · KOD
Kendall Healthcare Products Co....
Gastroenterology & Urology · 126d
Cleared Nov 12, 1993
MANAN ADAPTER FOR BIP BIOPSY DEVICE
K933448 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 121d
Cleared Nov 10, 1993
ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
K933868 · GCT
Angiolaz, Inc.
Gastroenterology & Urology · 96d
Cleared Nov 05, 1993
BIOPSY FORCEPS
K925392 · FCL
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 375d
Cleared Nov 04, 1993
FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR
K930171 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 295d
Cleared Nov 04, 1993
OLYMPUS GUIDE WIRE
K933110 · OCY
Olympus Corp.
Gastroenterology & Urology · 132d
Cleared Nov 02, 1993
THORACOSCOPE/LAPAROSCOPE
K931954 · GCM
Surgical Technologies, Inc.
Gastroenterology & Urology · 196d
Cleared Nov 02, 1993
KENDALL URODYNAMIC CATHETERS
K933399 · FEN
Kendall Healthcare Products Co....
Gastroenterology & Urology · 113d
Cleared Nov 02, 1993
OLYMPUS MEASURING DEVICES
K933717 · FDS
Olympus Corp.
Gastroenterology & Urology · 95d
Cleared Oct 25, 1993
FLEX-TECH BALLOON DILATOR
K926038 · KNQ
Cape Tech Medical Products
Gastroenterology & Urology · 328d
Cleared Oct 19, 1993
ENDOSCOPE
K933106 · ODF
Origin Medsystems, Inc.
Gastroenterology & Urology · 116d
Cleared Oct 13, 1993
STIMTECH PFX, CATALOG NUMBER 78-8540
K922562 · KPI
Stimtech Products
Gastroenterology & Urology · 499d
Cleared Oct 13, 1993
HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE
K932855 · KNT
Hollister, Inc.
Gastroenterology & Urology · 125d
Cleared Oct 08, 1993
FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE
K924996 · KNT
Abbott Laboratories
Gastroenterology & Urology · 372d
Cleared Oct 08, 1993
SILICONE RECTAL BALLOON
K930135 · FEN
Cook Urological, Inc.
Gastroenterology & Urology · 269d
Cleared Oct 04, 1993
OXY-BLOC
K931044 · MNK
Gi Supply
Gastroenterology & Urology · 217d
Cleared Sep 30, 1993
PERI-COMFORT(TM) SEATING CUSHION
K932396 · LRL
Chi'Am Intl.
Gastroenterology & Urology · 135d
Cleared Sep 28, 1993
INTHERM STASIS VALVE SYSTEM
K931025 · FGE
Interventional Therapeutics Corp.
Gastroenterology & Urology · 211d
Cleared Sep 28, 1993
TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
K931201 · OCX
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 203d