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
4585–4608 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 05, 1999
CYSTIC DUCT BALLOON DILATING CATHETER
K983154 · FGE
Applied Medical Resources
Gastroenterology & Urology · 238d
Cleared May 03, 1999
BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
K990376 · KNS
Ballard Medical Products
Gastroenterology & Urology · 84d
Cleared Apr 30, 1999
EXTRACORPOREAL BLOOD CIRCUIT
K982340 · FJK
Haidylena Medical Egypt
Gastroenterology & Urology · 298d
Cleared Apr 30, 1999
HP M2376A DEVICE LINK SYSTEM
K984194 · MQS
Hewlett-Packard Co.
Gastroenterology & Urology · 158d
Cleared Apr 30, 1999
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM,...
K990631 · FGE
Cordis Corp.
Gastroenterology & Urology · 63d
Cleared Apr 30, 1999
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
K991032 · FGE
Guidant Corp.
Gastroenterology & Urology · 32d
Cleared Apr 28, 1999
WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K983512 · FIP
Water Vault, Inc.
Gastroenterology & Urology · 203d
Cleared Apr 28, 1999
DAUM NEUROGATE TROCAR
K990782 · KNW
Daum GmbH
Gastroenterology & Urology · 50d
Cleared Apr 23, 1999
PBN DRAINAGE CATHETER GUIDEWIRES
K991097 · KNY
Medical Device Technologies, Inc.
Gastroenterology & Urology · 22d
Cleared Apr 21, 1999
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
K982413 · KDI
Gambro Healthcare
Gastroenterology & Urology · 282d
Cleared Apr 21, 1999
SERIM BLOOD LEAK TEST STRIP
K990206 · FJD
Serim Research Corp.
Gastroenterology & Urology · 90d
Cleared Apr 21, 1999
URETERAL ACCESS SHEATH SET
K990775 · FED
Applied Medical Resources
Gastroenterology & Urology · 43d
Cleared Apr 19, 1999
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
K990159 · FJI
Dynamic Technology Corp.
Gastroenterology & Urology · 90d
Cleared Apr 15, 1999
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON...
K974236 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 519d
Cleared Apr 15, 1999
ALTHIN MEDICAL AB ALTRACART II
K990010 · KPO
Althin Medical AB
Gastroenterology & Urology · 101d
Cleared Apr 14, 1999
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851
K982134 · KDI
Dynamic Technology Corp.
Gastroenterology & Urology · 301d
Cleared Apr 13, 1999
WILTEK HOT BIOPSY FORCEPS
K990231 · KGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Apr 06, 1999
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
K990863 · KNT
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 21d
Cleared Apr 02, 1999
STERICHEK TOTAL CHLORINE TEST KIT
K983997 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 143d
Cleared Mar 31, 1999
MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
K990220 · FCG
Medi-Globe Corp.
Gastroenterology & Urology · 68d
Cleared Mar 30, 1999
DAUM NEUROCUT NEUROBIOPSYNEEDLE
K990278 · KNW
Daum Corp.
Gastroenterology & Urology · 61d
Cleared Mar 30, 1999
COOPERSURGICAL INFRARED COAGULATOR FOR ENT
K990855 · KNS
CooperSurgical, Inc.
Gastroenterology & Urology · 15d
Cleared Mar 26, 1999
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
K982414 · KDI
Gambro Healthcare
Gastroenterology & Urology · 256d
Cleared Mar 26, 1999
URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042
K990050 · FGB
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 78d