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
2113–2136 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 07, 2014
MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES,...
K130616 · KNW
Biopsybell S.R.L.
Gastroenterology & Urology · 337d
Cleared Feb 07, 2014
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
K133263 · OZW
Proteus Digital Health, Inc.
Gastroenterology & Urology · 107d
Cleared Feb 06, 2014
FUSE 1C COLONOSCOPY SYSTEM
K132839 · FDF
Endochoice, Inc.
Gastroenterology & Urology · 149d
Cleared Feb 04, 2014
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
K132383 · LJE
Gyrus Acmi, Inc.
Gastroenterology & Urology · 188d
Cleared Feb 04, 2014
STREAMLINE EXPRESS
K132602 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 168d
Cleared Jan 31, 2014
NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD,...
K133796 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 49d
Not Cleared Jan 29, 2014
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
DEN120023 · PGD
Given Imaging , Ltd.
Gastroenterology & Urology · 426d
Cleared Jan 24, 2014
MACY CATHETER
K133881 · KNT
Hospi Corporation
Gastroenterology & Urology · 35d
Cleared Jan 24, 2014
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
K133987 · FDI
Boston Scientific Corporation
Gastroenterology & Urology · 29d
Cleared Jan 17, 2014
INJECTION NEEDLE
K132065 · FBK
Endochoice, Inc.
Gastroenterology & Urology · 198d
Cleared Jan 17, 2014
SUPRAPUBIC CATHETER AND INTRODUCER SET
K132890 · KOB
Mediplus , Ltd.
Gastroenterology & Urology · 123d
Cleared Jan 13, 2014
ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE
K130674 · KNT
Xeridiem Medical Devices
Gastroenterology & Urology · 306d
Cleared Jan 10, 2014
FUJIFILM 600 SERIES ENDOSCOPES
K132210 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 178d
Cleared Jan 09, 2014
CASCADE HEMODIALYSIS/APHERESIS CATHETER
K130851 · MSD
Health Line International Corporation
Gastroenterology & Urology · 288d
Cleared Jan 08, 2014
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM
K133747 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 08, 2014
OCCLUDER OCCLUSION BALLOON CATHETER
K133750 · EYB
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Jan 07, 2014
ENDOSCOPIC SUTURE CUTTER
K133736 · OCZ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 06, 2014
OPTIFLUX ULTRA DIALYZER
K123262 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 445d
Cleared Jan 06, 2014
INTONEMV
K133826 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 20d
Cleared Jan 03, 2014
PRISMAFLEX SYSTEM 7.10
K131516 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 220d
Cleared Jan 03, 2014
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K133312 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 67d
Cleared Jan 02, 2014
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
K131364 · FBO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 234d
Cleared Jan 02, 2014
GELPOINT PATH TRANSANAL ACCESS PLATFORM
K133393 · FER
Applied Medical Resources Corp.
Gastroenterology & Urology · 58d
Cleared Dec 31, 2013
REPROCESSED DILATING TIP TROCARS
K132629 · NLM
Stryker Sustainability Solutions
Gastroenterology & Urology · 131d