Cleared Traditional

K914449 - GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE (FDA 510(k) Clearance)

K914449 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device

Dec 1991

Decision

61d

Days

Class 2

Risk

K914449 is an FDA 510(k) clearance for the GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on December 4, 1991, 61 days after receiving the submission on October 4, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K914449 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 04, 1991
Decision Date	December 04, 1991
Days to Decision	61 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF