Cleared Traditional

K113229 - VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING (FDA 510(k) Clearance)

K113229 · C.R. Bard, Inc. · General & Plastic Surgery device

Jul 2012

Decision

261d

Days

Class 2

Risk

K113229 is an FDA 510(k) clearance for the VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on July 20, 2012, 261 days after receiving the submission on November 2, 2011.

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

Submission Details

510(k) Number	K113229 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 02, 2011
Decision Date	July 20, 2012
Days to Decision	261 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF