Cleared Traditional

K910586 - AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*
(FDA 510(k) Clearance)

K910586 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery

Mar 1991

Decision

24d

Days

Class 1

Risk

K910586 is an FDA 510(k) clearance for the AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*. This device is classified as a Staple, Removable (skin) (Class I — General Controls, product code GDT).

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on March 7, 1991, 24 days after receiving the submission on February 11, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4760.

Submission Details

510(k) Number	K910586 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 1991
Decision Date	March 07, 1991
Days to Decision	24 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—