Cleared Traditional

K810428 - VICRYL (FDA 510(k) Clearance)

K810428 · Ethicon, Inc. · General & Plastic Surgery device

Mar 1981

Decision

23d

Days

Class 2

Risk

K810428 is an FDA 510(k) clearance for the VICRYL. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on March 13, 1981, 23 days after receiving the submission on February 18, 1981.

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

Submission Details

510(k) Number	K810428 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 18, 1981
Decision Date	March 13, 1981
Days to Decision	23 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—