Cleared Traditional

K945060 - HERNIA MESH INTRODUCTION SYSTEM (FDA 510(k) Clearance)

K945060 · Gerard Medical, Inc. · General & Plastic Surgery device

Mar 1995

Decision

139d

Days

Class 2

Risk

K945060 is an FDA 510(k) clearance for the HERNIA MESH INTRODUCTION SYSTEM. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by Gerard Medical, Inc. (Charlton, US). The FDA issued a Cleared decision on March 2, 1995, 139 days after receiving the submission on October 14, 1994.

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

Submission Details

510(k) Number	K945060 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 14, 1994
Decision Date	March 02, 1995
Days to Decision	139 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement