Cleared Traditional

K070405 - MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
(FDA 510(k) Clearance)

K070405 · Cook Biotech, Inc. · General & Plastic Surgery device

Oct 2007

Decision

247d

Days

Class 2

Risk

K070405 is an FDA 510(k) clearance for the MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).

Submitted by Cook Biotech, Inc. (Lafeyette, US). The FDA issued a Cleared decision on October 17, 2007, 247 days after receiving the submission on February 12, 2007.

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

Submission Details

510(k) Number	K070405 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 12, 2007
Decision Date	October 17, 2007
Days to Decision	247 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF