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
4297–4320 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 25, 2000
KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL...
K001958 · MPB
Keystone Medical
Gastroenterology & Urology · 90d
Cleared Sep 14, 2000
14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD...
K993933 · MPB
Arrow Intl., Inc.
Gastroenterology & Urology · 301d
Cleared Sep 08, 2000
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
K001766 · FDS
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 88d
Cleared Aug 30, 2000
SPECTRUM SILICONE FOLEY CATHETER
K000251 · MJC
Cook Urological, Inc.
Gastroenterology & Urology · 216d
Cleared Aug 30, 2000
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
K001338 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 125d
Cleared Aug 29, 2000
NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
K001903 · KPI
Neotonus, Inc.
Gastroenterology & Urology · 68d
Cleared Aug 28, 2000
INTRASTENT DOUBLESTRUT PARAMOUNT
K001648 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 28, 2000
FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN...
K991495 · FIP
Fluid Process Systems, Inc.
Gastroenterology & Urology · 488d
Cleared Aug 25, 2000
FRESENIUS OPTIFLUX 200NR
K002277 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Aug 25, 2000
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
K994198 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 256d
Cleared Aug 24, 2000
LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 &...
K001633 · MSD
Vasca, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 18, 2000
FLO ASSISTANT, MODEL 4-250-00
K001325 · LJH
Northgate Technologies, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 17, 2000
NDO SURGICAL SURGICAL OVERTUBE
K002018 · FED
Surgical, Inc.
Gastroenterology & Urology · 45d
Cleared Aug 16, 2000
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
K001250 · KDI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 119d
Cleared Aug 14, 2000
DIALGUARD ENDOTOXIN REMOVAL DEVICE
K993806 · FIP
Clarigen, Inc.
Gastroenterology & Urology · 279d
Cleared Aug 10, 2000
SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)
K994231 · ODA
Siemens Medical Corp.
Gastroenterology & Urology · 238d
Cleared Aug 08, 2000
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
K000388 · KPL
Clearwater Colon Hydrotherapy, Inc.
Gastroenterology & Urology · 183d
Cleared Aug 03, 2000
DETRUSAN 500
K994109 · KPI
Innovamed USA, Inc.
Gastroenterology & Urology · 241d
Cleared Aug 01, 2000
A.V. FISTULA NEEDLE
K001496 · FIE
Exelint International, Co.
Gastroenterology & Urology · 78d
Cleared Jul 31, 2000
PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
K001515 · KPI
The Prometheus Group
Gastroenterology & Urology · 76d
Cleared Jul 31, 2000
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
K002101 · FGE
AngioDynamics, Inc.
Gastroenterology & Urology · 49d
Cleared Jul 31, 2000
ADVANCED UROSCIENCE INJECTION NEEDLE
K002323 · FBK
Advanced Uroscience, Inc.
Gastroenterology & Urology · 34d
Cleared Jul 28, 2000
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
K001873 · FJK
Fresenius Medical Care North America
Gastroenterology & Urology · 38d
Cleared Jul 26, 2000
GASTRIC LAVAGE VALVE
K990365 · KNT
T-Med Vac Corporation
Gastroenterology & Urology · 537d