510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K910914Substantially Equivalent

Surgical Tissue Pouch

Cook Incorporated, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910914 is the FDA 510(k) clearance record for SURGICAL TISSUE POUCH, a class I device, cleared for Cook Urological, Inc. on under FDA product code KGY (Bag, Intestine). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show one recall naming K910914.

Clearance record

Decision date
Received
(23 days to decision)
Product code
KGY Bag, Intestine
Regulation
21 CFR 878.4100
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
Third party review
No

Clearances, product code KGY

Trailing 12 months

FDA records hold no clearances under product code KGY in the trailing twelve months.

FDA records show no clearances under product code KGY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260