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
3169–3192 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 21, 2006
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Sep 15, 2006
NUTRISAFE 2
K060944 · FPD
Vygon Corp.
Gastroenterology & Urology · 162d
Cleared Sep 15, 2006
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
K061877 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 74d
Cleared Sep 11, 2006
HOSPIRA ENTERAL FEEDING SET, MODEL 20640
K061432 · KNT
Hospira, Inc.
Gastroenterology & Urology · 110d
Cleared Sep 11, 2006
RENALSOFT
K061515 · KPF
Baxter Healthcare Corp
Gastroenterology & Urology · 102d
Cleared Sep 08, 2006
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
K060333 · FIN
Dialysis Services, Inc.
Gastroenterology & Urology · 211d
Cleared Sep 06, 2006
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
K060623 · FER
Cook Ireland, Ltd.
Gastroenterology & Urology · 182d
Cleared Sep 06, 2006
PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
K062042 · LIL
Plethora Solutions
Gastroenterology & Urology · 49d
Cleared Sep 05, 2006
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031
K060734 · LKN
Fresenius Medical Care North America
Gastroenterology & Urology · 169d
Cleared Sep 05, 2006
RB12 SUCTION RECTAL BIOPSY SYSTEM
K062159 · FCK
Aus Systems Pty , Ltd.
Gastroenterology & Urology · 39d
Cleared Sep 01, 2006
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
K060288 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 207d
Cleared Sep 01, 2006
WELLFLEX BILIARY RX STENT SYSTEM
K061231 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 122d
Cleared Aug 31, 2006
BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5
K053556 · MNW
Jawon Medical Co., Ltd.
Gastroenterology & Urology · 254d
Cleared Aug 31, 2006
PRIMUS GPS BILIARY STENT SYSTEM
K061566 · FGE
Ev3, Inc.
Gastroenterology & Urology · 86d
Cleared Aug 21, 2006
KSEA BIPOLAR ELECTROTOME
K061541 · FAS
Ksea
Gastroenterology & Urology · 77d
Cleared Aug 18, 2006
FOLEY CATHETERS WITH TEMPERATURE PROBE
K061918 · EYC
Ge Healthcare
Gastroenterology & Urology · 43d
Cleared Aug 15, 2006
SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY...
K060557 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 166d
Cleared Aug 15, 2006
NAVIAID BGE DEVICE, MODEL 21-001
K060923 · FDA
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 133d
Cleared Aug 04, 2006
ENDO-EASE ENDOSCOPIC OVERTUBE
K060235 · FDA
Spirus Medical, Inc.
Gastroenterology & Urology · 186d
Cleared Aug 04, 2006
MARATHON STENT WITH FUSION TECHNOLOGY
K060624 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 149d
Cleared Aug 04, 2006
KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE...
K060972 · MSD
Kendall
Gastroenterology & Urology · 119d
Cleared Jul 31, 2006
NXSTAGE CARTRIDGE EXPRESS
K061837 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 32d
Cleared Jul 18, 2006
SMARTPILL GI MONITORING SYSTEM
K053547 · NYV
The Smartpill Corporation
Gastroenterology & Urology · 210d
Cleared Jul 18, 2006
EMBEDDING TOOL, MODEL TE-1000
K060897 · FJS
Medigroup, Inc.
Gastroenterology & Urology · 106d