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
7033–7056 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 21, 1989
WILTEK CYTOLOGY BRUSH
K894863 · FDX
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK BALLOON STONE EXTRACTOR
K894865 · LQR
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK STONE EXTRACTOR
K894866 · LQR
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK E.R.C.P. CATHETER
K894867 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK VARICES INJECTION NEEDLE
K894868 · FBK
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK POLYPECTOMY SNARE
K894869 · FDI
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK NASAL BILIARY DRAINAGE SET
K894870 · BSS
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK BILIARY STENT SET
K894871 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 18, 1989
METAL URETERAL BASKET STONE DISLODGER
K896169 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 54d
Cleared Dec 13, 1989
AMCATH URETERAL DILATORS MODELS 7100,7110,7120
K894925 · EZN
Intec Medical, Inc.
Gastroenterology & Urology · 133d
Cleared Dec 13, 1989
BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE
K895199 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 117d
Cleared Dec 08, 1989
RECTUM-COLON MOTILITY MONITOR
K884920 · FAP
Multi-Spectrum Consulting, Inc.
Gastroenterology & Urology · 375d
Cleared Dec 08, 1989
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
K894939 · FPD
North American Sterilization &...
Gastroenterology & Urology · 127d
Cleared Dec 08, 1989
WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT
K896069 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 01, 1989
3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET
K894986 · OCZ
North American Sterilization &...
Gastroenterology & Urology · 115d
Cleared Dec 01, 1989
SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO.
K896163 · FGE
Schneider Stent
Gastroenterology & Urology · 38d
Cleared Nov 30, 1989
STERILE FOLEY CATHETER
K890310 · EYC
Kosan Far East Ent. , Ltd.
Gastroenterology & Urology · 311d
Cleared Nov 30, 1989
PORGES HOT BIOPSY FORCEPS
K896537 · KGE
Porges Corp.
Gastroenterology & Urology · 15d
Cleared Nov 28, 1989
MOP CATHETER
K891239 · KDL
Bivona Medical Technologies
Gastroenterology & Urology · 266d
Cleared Nov 28, 1989
ABBOTT INPERSOL CYCLER 1000
K895336 · FKX
Abbott Laboratories
Gastroenterology & Urology · 89d
Cleared Nov 24, 1989
MEDISYSTEMS TRANSDUCER PROTECTOR
K895856 · FIB
Medisystems Corp.
Gastroenterology & Urology · 53d
Cleared Nov 21, 1989
AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP
K894794 · KPM
Vitaid, Ltd.
Gastroenterology & Urology · 116d
Cleared Nov 17, 1989
URETHRAL BALLOON DILATION CATHETER SET
K892855 · KOE
Cook Urological, Inc.
Gastroenterology & Urology · 213d
Cleared Nov 13, 1989
BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))
K895251 · KPN
C.R. Bard, Inc.
Gastroenterology & Urology · 84d