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
7081–7104 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 03, 1989
BIOPSY FORCEPS
K892252 · FCL
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 182d
Cleared Oct 03, 1989
VAS-CATH URETERAL STENT CATHETER
K894357 · FAD
Vas-Cath, Inc.
Gastroenterology & Urology · 81d
Cleared Oct 03, 1989
PEDI-TUBE(R) STYLET
K894857 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 29, 1989
URETHRAL AND URETERAL BALLOON DILATATORS
K884711 · EZN
Primrose Medical, Inc.
Gastroenterology & Urology · 325d
Cleared Sep 29, 1989
COLONIC BALLOON DIALATORS
K884713 · FFP
Primrose Medical, Inc.
Gastroenterology & Urology · 325d
Cleared Sep 29, 1989
BILIARY DIALATOR
K884714 · FGE
Primrose Medical, Inc.
Gastroenterology & Urology · 325d
Cleared Sep 29, 1989
ACHELASIA BALLOON DIALATOR
K884715 · KNQ
Primrose Medical, Inc.
Gastroenterology & Urology · 325d
Cleared Sep 29, 1989
FIBER OPTIC LIGHT TRANSMISSION CABLE
K892145 · FFS
Opto Vision, Inc.
Gastroenterology & Urology · 183d
Cleared Sep 29, 1989
DENVER PERITONEO-VENUS SHUNT
K894756 · KPM
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 28, 1989
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)
K891588 · LQR
Ideal Medical, Inc.
Gastroenterology & Urology · 195d
Cleared Sep 25, 1989
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K885220 · KNT
Ethox Corp.
Gastroenterology & Urology · 279d
Cleared Sep 25, 1989
MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM
K892895 · KNS
Everest Medical Corp.
Gastroenterology & Urology · 153d
Cleared Sep 22, 1989
NATIONAL MEDICAL CARE VENOUS LINE 03-9548
K894637 · KOC
National Medical Care, Medical...
Gastroenterology & Urology · 60d
Cleared Sep 12, 1989
MODIFIED URINARY CATHETER INTRODUCER (UCI)
K890400 · KOD
Go Medical Industries Pty. , Ltd.
Gastroenterology & Urology · 231d
Cleared Sep 08, 1989
ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
K884709 · ODD
Primrose Medical, Inc.
Gastroenterology & Urology · 304d
Cleared Sep 08, 1989
ESOPHAGEAL AND PYLORIC BALLOON DIALATORS
K884712 · KNQ
Primrose Medical, Inc.
Gastroenterology & Urology · 304d
Cleared Sep 08, 1989
RUBENSTEIN URETERAL STONE FRAGMENT BRUSH
K885168 · FGO
Boston Scientific Corp
Gastroenterology & Urology · 269d
Cleared Sep 08, 1989
BIPOLAR ELECTROSURGICAL SNARE
K893553 · FDI
Everest Medical Corp.
Gastroenterology & Urology · 123d
Cleared Sep 08, 1989
NOETIX, BIOPSY NEEDLE
K893992 · KNW
Noetix, Inc.
Gastroenterology & Urology · 95d
Cleared Sep 08, 1989
GASTRO ENTEROLOGICAL BIOPTOME
K894419 · KNW
Symbiosis Corp.
Gastroenterology & Urology · 53d
Cleared Sep 08, 1989
LAMANO DIRECTORS
K894592 · GCM
Marlo Surgical Technology
Gastroenterology & Urology · 46d
Cleared Sep 07, 1989
MODIFIED PRISTINE CULTURE CATHETER
K893390 · KOD
Hml Medical, Inc.
Gastroenterology & Urology · 129d
Cleared Sep 07, 1989
PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP
K894783 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 42d
Cleared Sep 07, 1989
HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB
K894838 · FKP
Baxter Healthcare Corp
Gastroenterology & Urology · 38d