Cleared Traditional

XENMATRIX AB SURGICAL GRAFT

K133223 · C.R. Bard, Inc. · General & Plastic Surgery

Sep 2014

Decision

333d

Days

Class 2

Risk

About This 510(k) Submission

K133223 is an FDA 510(k) clearance for the XENMATRIX AB SURGICAL GRAFT, a Collagen Surgical Mesh Containing Drugs (Class II — Special Controls, product code PIJ), submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on September 19, 2014, 333 days after receiving the submission on October 21, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K133223 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2013
Decision Date	September 19, 2014
Days to Decision	333 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	PIJ — Collagen Surgical Mesh Containing Drugs
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	Reinforcement Of Soft Tissue Where Weakness Exists.