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
9745–9768 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 21, 1977
UNIVERSAL TRAY
K770496 · FCM
Concord Laboratories, Inc.
Gastroenterology & Urology · 7d
Cleared Mar 21, 1977
DRAINAGE UNIT, COMBINATION
K770497 · KNX
Concord Laboratories, Inc.
Gastroenterology & Urology · 7d
Cleared Mar 16, 1977
TYGON M-60/TYGON M-70
K770299 · FID
Norton Performance Plastics Corp.
Gastroenterology & Urology · 30d
Cleared Mar 16, 1977
URINARY DRAINAGE SET, CLOSED, STERILE
K770320 · KNX
Medical Devices, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 16, 1977
PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2
K770475 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 5d
Cleared Mar 15, 1977
KARAYA GUM POWDER, OSTOMY
K770408 · EZK
Howmedica Corp.
Gastroenterology & Urology · 11d
Cleared Mar 10, 1977
RADIOEAR MODEL 1072
K770402
Radioear Corp.
Gastroenterology & Urology · 7d
Cleared Mar 09, 1977
ARGYLE RAPID GASTRIC LAVAGE KIT
K770248 · KDH
Sherwood Medical Industries
Gastroenterology & Urology · 30d
Cleared Mar 09, 1977
VALVE FOR CLOSED SYS. URINARY DRAINAGE
K770399 · KNX
Will Ross Co.
Gastroenterology & Urology · 7d
Cleared Mar 08, 1977
DIALYSIS DELIVERY SYS., ULTIM. MODEL II
K770350 · FKP
Vital Systems, Inc.
Gastroenterology & Urology · 14d
Cleared Mar 08, 1977
NEEDLE, FISTULA, ERIKA
K770382 · KOC
Erika, Inc.
Gastroenterology & Urology · 8d
Cleared Mar 07, 1977
OSTOMY KARAYA GUM POWDER
K761340 · EZR
Howmedica Corp.
Gastroenterology & Urology · 69d
Cleared Mar 07, 1977
STOPCOCK, ONE WAY
K770383 · KOC
Cobe Laboratories, Inc.
Gastroenterology & Urology · 7d
Cleared Mar 01, 1977
TRAY, URETHRAL CATHETERIZATION
K760048 · FCM
M-C Ind., Inc.
Gastroenterology & Urology · 259d
Cleared Feb 28, 1977
TUBE, GASTRO-ENTEROSTOMY
K760810 · EXD
Sherwood Medical Industries
Gastroenterology & Urology · 149d
Cleared Feb 28, 1977
KARAYA GUM POWDER
K770230 · EZR
Atlantic Surgical
Gastroenterology & Urology · 21d
Cleared Feb 28, 1977
SUPER X ADJUSTRETTE
K770251 · EXD
Qualitone
Gastroenterology & Urology · 19d
Cleared Feb 24, 1977
ANAL/RECTAL SYRINGE
K761229 · KOA
Ace Orthopedic Manufacturing Co.
Gastroenterology & Urology · 76d
Cleared Feb 18, 1977
DIALYSATE METER RS-2100A, CIRCUIT CHANGE
K770263 · FLB
Renal Systems, Inc.
Gastroenterology & Urology · 7d
Cleared Feb 18, 1977
SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125
K770291 · FAM
Welch Allyn, Inc.
Gastroenterology & Urology · 4d
Cleared Feb 17, 1977
IRRIGATION CATHETER
K760556 · KDH
Sherwood Medical Industries
Gastroenterology & Urology · 169d
Cleared Feb 17, 1977
CATHETERS, SILICONE COATED
K770256 · KOD
Pharmaseal Div., Baxter Healthcare Corp.
Gastroenterology & Urology · 7d
Cleared Feb 15, 1977
KARAYA GUM PRODUCTS - PROCESS CHANGE
K761319 · EZR
Howmedica Corp.
Gastroenterology & Urology · 50d
Cleared Feb 07, 1977
BARIOR
K770213 · KOC
Tri-Med, Inc.
Gastroenterology & Urology · 5d