Cleared Traditional

K910914 - SURGICAL TISSUE POUCH
(FDA 510(k) Clearance)

K910914 · Cook Urological, Inc. · General & Plastic Surgery device

Mar 1991

Decision

23d

Days

Class 1

Risk

K910914 is an FDA 510(k) clearance for the SURGICAL TISSUE POUCH. This device is classified as a Bag, Intestine (Class I - General Controls, product code KGY).

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on March 28, 1991, 23 days after receiving the submission on March 5, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4100.

Submission Details

510(k) Number	K910914 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 05, 1991
Decision Date	March 28, 1991
Days to Decision	23 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—