Cleared Traditional

K051701 - VICRYL * MESH BAG (FDA 510(k) Clearance)

K051701 · Ethicon, Inc. · General & Plastic Surgery device

Sep 2005

Decision

97d

Days

Class 2

Risk

K051701 is an FDA 510(k) clearance for the VICRYL * MESH BAG. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on September 29, 2005, 97 days after receiving the submission on June 24, 2005.

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

Submission Details

510(k) Number	K051701 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 24, 2005
Decision Date	September 29, 2005
Days to Decision	97 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF