Cleared Traditional

K972412 - PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH (FDA 510(k) Clearance)

K972412 · Ethicon, Inc. · General & Plastic Surgery device

Sep 1997

Decision

76d

Days

Class 2

Risk

K972412 is an FDA 510(k) clearance for the PROLENE POLYPROPYLENE MESH HERNIA DEVICE 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 September 10, 1997, 76 days after receiving the submission on June 26, 1997.

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

Submission Details

510(k) Number	K972412 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 26, 1997
Decision Date	September 10, 1997
Days to Decision	76 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF