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
6481–6504 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 23, 1991
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K912972 · FPD
Abbott Laboratories
Gastroenterology & Urology · 77d
Cleared Sep 23, 1991
BODEN WHEELCHAIR DRAINAGE SYSTEM
K913142 · KNX
Mno Medical Products
Gastroenterology & Urology · 69d
Cleared Sep 23, 1991
ETUDE (MODEL NUMBERS 24A05 & 24A06)
K913323 · FAP
Dantec Medical, Inc.
Gastroenterology & Urology · 60d
Cleared Sep 19, 1991
TROCAR (FALLER STYLET)
K910786 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 206d
Cleared Sep 17, 1991
MEDI-KLEER
K904871 · OCT
North American Marketing Corp.
Gastroenterology & Urology · 323d
Cleared Sep 13, 1991
INTHERM RADIALLY EXPANDING DILATER
K912971 · FGE
Interventional Therapeutics Corp.
Gastroenterology & Urology · 67d
Cleared Sep 10, 1991
COX DISPOSABLE CYTOLOGY BRUSHES
K912407 · FDX
Cox Medical Ent., Inc.
Gastroenterology & Urology · 103d
Cleared Sep 10, 1991
BARD(R) DISPOSABLE BIOPSY FORCEPS
K912549 · FCL
C.R. Bard, Inc.
Gastroenterology & Urology · 92d
Cleared Sep 05, 1991
WILSON-COOK RUSSELL GASTROSTOMY KIT
K912047 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Sep 05, 1991
UNIVERSAL SWIVEL PATCH
K913679 · KNY
Bryman Medical
Gastroenterology & Urology · 17d
Cleared Sep 04, 1991
DRY TIME
K911279 · KPN
Health Sense Intl., Inc.
Gastroenterology & Urology · 163d
Cleared Sep 04, 1991
IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS
K912531 · FET
Innovative Medical Devices, Inc.
Gastroenterology & Urology · 89d
Cleared Sep 04, 1991
STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES
K913223 · KNX
Medical Device Inspection Co., Inc.
Gastroenterology & Urology · 47d
Cleared Aug 30, 1991
TRANSDUCER PROTECTOR
K912394 · FIB
Filtertek, Inc.
Gastroenterology & Urology · 94d
Cleared Aug 28, 1991
JMS AV FISTULA NEEDLES
K911199 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Aug 22, 1991
TITANIUM CATHETER EXTENDER
K910785 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 178d
Cleared Aug 20, 1991
DRAINAGE CATHETERS W/A DISSOLVABLE TIP
K900205 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 581d
Cleared Aug 16, 1991
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
K910190 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 212d
Cleared Aug 16, 1991
BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF
K910846 · EZC
C.R. Bard, Inc.
Gastroenterology & Urology · 170d
Cleared Aug 16, 1991
OLYMOUS XLS XENON LIGHT SOURCE
K912354 · GCT
Perkinelmer Optoelectronics
Gastroenterology & Urology · 80d
Cleared Aug 16, 1991
CANDELA INTRODUCER SHEATH SYSTEM
K912443 · FDE
Candela Laser Corp.
Gastroenterology & Urology · 74d
Cleared Aug 15, 1991
NORTEC URETERAL STENT
K910691 · FAD
North American Sterilization &...
Gastroenterology & Urology · 177d
Cleared Aug 15, 1991
TITANIUM CONNECTOR (2 PART)
K910787 · FKO
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 171d
Cleared Aug 15, 1991
DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020
K911125 · FAP
Diagnostic Ultrasound Corp.
Gastroenterology & Urology · 155d