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
6577–6600 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 30, 1991
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
K903345 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 279d
Cleared Apr 29, 1991
PERMANENT SILICONE CATHETERS
K910501 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 29, 1991
VESSEL DILATORS
K910502 · FKA
Akcess Medical Products, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 29, 1991
INTRODUCER NEEDLES
K910641 · KOC
Akcess Medical Products, Inc.
Gastroenterology & Urology · 75d
Cleared Apr 25, 1991
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
K910214 · FAE
American Medical Corp.
Gastroenterology & Urology · 98d
Cleared Apr 25, 1991
WILSON-COOK DISPOSABLE BIOPSY FORCEPS
K910656 · FLC
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 25, 1991
KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER
K911242 · KOD
Kendall Healthcare Products Co....
Gastroenterology & Urology · 35d
Cleared Apr 25, 1991
KENDALL PEDIATRIC URINE METER
K911258 · EXR
Kendall Healthcare Products Co....
Gastroenterology & Urology · 34d
Cleared Apr 25, 1991
BARD 3000 PLUS URETEROSCOPY SYSTEM
K911411 · FGB
C.R. Bard, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 24, 1991
ACID CONCENTRATE SOLUTIONS
K910319 · KPO
Biopharm, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 22, 1991
LAPAROSCOPIC CLEANING BRUSH INSTRUMENT
K911481 · FDX
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 18d
Cleared Apr 22, 1991
LAPAROSCOPIC SNARE
K911482 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 18d
Cleared Apr 19, 1991
STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED
K905838 · LJT
Strato Medical Corp.
Gastroenterology & Urology · 113d
Cleared Apr 19, 1991
ARGYLE POLYURETHANE SALEM SUMP TUBE
K910479 · BSS
Sherwood Medical Co.
Gastroenterology & Urology · 72d
Cleared Apr 19, 1991
MOSS GASTROSTOMY TUBE
K910913 · KNT
Moss Medical Products
Gastroenterology & Urology · 45d
Cleared Apr 18, 1991
PREMIXED DIALYSATE FOR HEMODIAFILTRATION
K910270 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 85d
Cleared Apr 18, 1991
ENDOPATH VERESS NEEDLE
K910855 · FHP
Symbiosis Corp.
Gastroenterology & Urology · 49d
Cleared Apr 18, 1991
INTIMAX(TM) IRRIGATION CATHETER
K911181 · GCA
Applied Vascular Devices, Inc.
Gastroenterology & Urology · 31d
Cleared Apr 16, 1991
Y ADAPTOR
K910321 · KOC
Akcess Medical Products, Inc.
Gastroenterology & Urology · 82d
Cleared Apr 16, 1991
MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE
K910716 · FCX
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 55d
Cleared Apr 16, 1991
INPERSOL CAPD BIOCAP ADMINISTRATION SET
K911094 · KDI
Abbott Laboratories
Gastroenterology & Urology · 34d
Cleared Apr 16, 1991
MULTIPLE BIOPSY DEVICE-MBX
K911448 · FCK
Triton Technology, Inc.
Gastroenterology & Urology · 32d
Cleared Apr 12, 1991
ACCENT DG BALLOON URETERAL DILATOR SET
K905375 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 133d
Cleared Apr 12, 1991
CANDELA MINI-UB ENDOSCOPE
K910732 · ODF
Candela Laser Corp.
Gastroenterology & Urology · 50d