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
4465–4488 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 18, 1999
WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS
K983239 · FIP
Rasco
Gastroenterology & Urology · 429d
Cleared Nov 18, 1999
11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE,...
K992813 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 17, 1999
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13,...
K993588 · FGE
Guidant Corp.
Gastroenterology & Urology · 26d
Cleared Nov 16, 1999
SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
K992793 · FIN
Better Water, Inc.
Gastroenterology & Urology · 89d
Cleared Nov 10, 1999
MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
K991320 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 205d
Cleared Nov 10, 1999
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS...
K992713 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 90d
Cleared Nov 05, 1999
COLDLIGHTSOURCE PL3000
K993300 · FCW
Fiber Imaging Technologies, Inc.
Gastroenterology & Urology · 35d
Cleared Nov 05, 1999
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
K993459 · PAG
Advanced Uroscience, Inc.
Gastroenterology & Urology · 23d
Cleared Nov 04, 1999
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1
K990229 · KDN
Justec Medical Products, Inc.
Gastroenterology & Urology · 283d
Cleared Nov 03, 1999
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
K991672 · FCG
Olympus America, Inc.
Gastroenterology & Urology · 170d
Cleared Oct 29, 1999
NUTRISAFE EXTENSION TUBE
K991918 · KNT
Vygon Corp.
Gastroenterology & Urology · 144d
Cleared Oct 29, 1999
PALMAZ XL TANSHEPATIC BILIARY STENTS
K993091 · FGE
Cordis Corp.
Gastroenterology & Urology · 43d
Cleared Oct 27, 1999
SHELLY PROTECTED AV FISTULA NEEDLE
K992653 · FIE
Diasol, Inc.
Gastroenterology & Urology · 82d
Cleared Oct 22, 1999
DRYASOL ACID CONCENTRATE MIX
K993212 · KPO
Diasol, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 21, 1999
MEDTRONIC AVE BRIDGE STENT
K993145 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 31d
Cleared Oct 20, 1999
50 W METAL HALIDE ILLUMINATOR, VES 0501.
K992447 · FCW
Angiolaz, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 20, 1999
BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT
K993138 · KNT
Ballard Medical Products
Gastroenterology & Urology · 30d
Cleared Oct 15, 1999
KSEA SCBCOM
K992469 · FET
Karl Storz Endoscopy
Gastroenterology & Urology · 81d
Cleared Oct 15, 1999
MODIFICATION TO INTRASTENT
K992816 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 56d
Cleared Oct 13, 1999
NEO-2 METER
K992431 · FIZ
Automata Instrumentation, Inc.
Gastroenterology & Urology · 84d
Cleared Oct 13, 1999
URETERO-RENOSCOPE
K992527 · FGB
Fiber Imaging Technologies, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 08, 1999
RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
K992319 · FGE
Guidant Corp.
Gastroenterology & Urology · 88d
Cleared Oct 07, 1999
BAHO AUTOCLAVABLE CYSTOSCOPE
K992983 · FAJ
Innovative Endoscopy Components, LLC
Gastroenterology & Urology · 34d
Cleared Oct 06, 1999
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K993064 · KDI
Gambro Renal Care Products
Gastroenterology & Urology · 23d