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
7729–7752 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 07, 1986
COOK-VPI INTERMITTENT CATHETER
K863082 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 07, 1986
GAMBRO FLUID CONTROL MONITOR FCM 10-1
K864094 · FKP
Gambro, Inc.
Gastroenterology & Urology · 17d
Cleared Nov 06, 1986
AMICON DIAFILTER HEMOFILTER
K863823 · KDI
Amicon, Inc.
Gastroenterology & Urology · 37d
Cleared Nov 06, 1986
GAMBRO BICARBONATE MONITOR BCM 10-2
K864083 · FKP
Gambro, Inc.
Gastroenterology & Urology · 17d
Cleared Nov 06, 1986
FRESENIUS HEMOFLOW F50 & F70
K864169 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 13d
Cleared Nov 04, 1986
SHEATH, ENDOSCOPE
K862059 · FGE
Endovations
Gastroenterology & Urology · 158d
Cleared Nov 04, 1986
CRAIG NASO-GASTRIC TUBE HOLDER
K862855 · KNT
Henley Intl.
Gastroenterology & Urology · 98d
Cleared Nov 04, 1986
MARTIN MEDICAL PRO-SCOPE ANOSCOPE
K863273 · KOA
Martin Medical
Gastroenterology & Urology · 71d
Cleared Nov 04, 1986
BIO-GUARD AB COATED CATHETER
K863354 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 67d
Cleared Nov 04, 1986
BILIARY BALLOON CATHETER
K863571 · FGE
Uresil Corp.
Gastroenterology & Urology · 53d
Cleared Nov 04, 1986
TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY
K863958 · KOD
Cathaid, Inc.
Gastroenterology & Urology · 25d
Cleared Oct 31, 1986
NEPHROSTOMY SET
K862742 · LJE
Meadox Surgimed, Inc.
Gastroenterology & Urology · 102d
Cleared Oct 31, 1986
HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER
K862949 · LQR
Oscor Medical Corp.
Gastroenterology & Urology · 87d
Cleared Oct 31, 1986
CARE + PLUS IRREGATION TRAY
K863281 · KOD
Welmed Systems, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 31, 1986
CARE + PLUS CATHETER CARE TRAY
K863282 · KOD
Welmed Systems, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 31, 1986
FOLEY CATHETERS
K863517 · KOD
Instrumentation Industries, Inc.
Gastroenterology & Urology · 52d
Cleared Oct 29, 1986
STARCHILD SLEEPDRY
K862757 · KPN
Starchild, Inc.
Gastroenterology & Urology · 99d
Cleared Oct 29, 1986
BARD BALLOON DILATATION SYSTEM
K863437 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 54d
Cleared Oct 29, 1986
HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES
K863720 · FIP
Water Pure, Inc.
Gastroenterology & Urology · 36d
Cleared Oct 28, 1986
MODEL 4-SC FOUR WAY STOPCOCK
K863165 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 71d
Cleared Oct 24, 1986
PENN 3-RING HANDLE
K862729 · FFL
Penn Medical Devices, Inc.
Gastroenterology & Urology · 98d
Cleared Oct 24, 1986
FLEXIBLE VISUALIZATION CATHETER
K862872 · FEI
American Edwards Laboratories
Gastroenterology & Urology · 86d
Cleared Oct 24, 1986
4-WIRE (CARSON) STONE EXTRACTOR
K863081 · FFL
Cook Urological, Inc.
Gastroenterology & Urology · 73d
Cleared Oct 24, 1986
(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET
K863120 · KOB
Cook Urological, Inc.
Gastroenterology & Urology · 71d