Cleared Traditional

K051048 - SURGISIS STAPLE LINE REINFORCEMENT II
(FDA 510(k) Clearance)

K051048 · Cook Biotech, Inc. · General & Plastic Surgery device

Sep 2005

Decision

151d

Days

Class 2

Risk

K051048 is an FDA 510(k) clearance for the SURGISIS STAPLE LINE REINFORCEMENT II. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on September 23, 2005, 151 days after receiving the submission on April 25, 2005.

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

Submission Details

510(k) Number	K051048 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 25, 2005
Decision Date	September 23, 2005
Days to Decision	151 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF