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
9697–9720 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 02, 1977
PFISTER-SCHWARTZ STONE RETRIEVER
K771302 · FGO
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 18d
Cleared Aug 02, 1977
MODIFICATION TO KIDNEY DIALYZER
K771349 · FHS
Erika, Inc.
Gastroenterology & Urology · 12d
Cleared Aug 02, 1977
LUBE JEL
K771364 · FHX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 8d
Cleared Aug 02, 1977
CHOLEDOCHOSCOPE SYSTEM
K771367 · FBN
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 8d
Cleared Jul 29, 1977
NEEDLE, CHIBA UNIVERSITY
K771108 · FCG
Johannah Medical Services, Inc.
Gastroenterology & Urology · 39d
Cleared Jul 19, 1977
CATHETERS, DRAINAGE
K771048 · FEG
Axiom Medical, Inc.
Gastroenterology & Urology · 39d
Cleared Jul 15, 1977
UNITED SKIN BARRIER
K770982 · EXE
Howmedica Corp.
Gastroenterology & Urology · 45d
Cleared Jul 15, 1977
AV FISTULA NEEDLE SET
K771206 · FIE
Terumo America, Inc.
Gastroenterology & Urology · 10d
Cleared Jul 11, 1977
CATHETER, SAMPLING, CONDUIT
K771066 · FEZ
Mentor Corp.
Gastroenterology & Urology · 28d
Cleared Jul 11, 1977
UROGARD URINARY DRAINAGE BAG
K771210 · FCN
Terumo America, Inc.
Gastroenterology & Urology · 6d
Cleared Jun 28, 1977
POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE
K770826 · FON
Howmedica Corp.
Gastroenterology & Urology · 54d
Cleared Jun 24, 1977
HEMODIALYSIS FISTULA SET
K770864 · FIE
Venospital, Inc.
Gastroenterology & Urology · 44d
Cleared Jun 24, 1977
DYLADE, MODEL DS
K771065 · FKP
Milton Roy Co. Analytical
Gastroenterology & Urology · 11d
Cleared Jun 24, 1977
URETHRAL TRAY W/CATHETER, 7750
K771103 · FCM
Concord Laboratories, Inc.
Gastroenterology & Urology · 4d
Cleared Jun 24, 1977
URETHRAL TRAY W/OUT CAHTETER, 7650
K771104 · FCM
Concord Laboratories, Inc.
Gastroenterology & Urology · 4d
Cleared Jun 14, 1977
NEEDLE SET, A-V FISTULA
K770699 · FIE
Medical Disposables Intl., Inc.
Gastroenterology & Urology · 57d
Cleared Jun 14, 1977
DIALYZER, ULTRADIFFUSER, DISPOSABLE
K770858 · FJG
Gambro, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 14, 1977
DIALYZER, FIBER, HOLLOW
K770867 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 33d
Cleared Jun 03, 1977
URODYNAMIC INSTRUMENTS
K770897 · EXY
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 18d
Cleared Jun 03, 1977
URINE TESTER, MODEL 701
K770939 · EXR
Brother Scientific Products, Inc.
Gastroenterology & Urology · 11d
Cleared Jun 01, 1977
ANOSCOPE, OPTIC, FIBER
K770906 · FER
Welch Allyn, Inc.
Gastroenterology & Urology · 14d
Cleared Jun 01, 1977
UROLOGICAL BIOPSY BRUSH SET
K770913 · FDX
Cook, Inc.
Gastroenterology & Urology · 13d
Cleared May 25, 1977
BRONCHOFIBERSCOPE, FB-19A
K770879
Pilling Co.
Gastroenterology & Urology · 9d
Cleared May 23, 1977
CATHETER, URETHRAL PRESSURE, UPE-10 & 12
K770579 · FAP
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 56d