Cleared Traditional

K010722 - PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH (FDA 510(k) Clearance)

K010722 · Ethicon, Inc. · General & Plastic Surgery device

Apr 2001

Decision

46d

Days

Class 2

Risk

K010722 is an FDA 510(k) clearance for the PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH. 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 April 27, 2001, 46 days after receiving the submission on March 12, 2001.

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

Submission Details

510(k) Number	K010722 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 12, 2001
Decision Date	April 27, 2001
Days to Decision	46 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF