Cleared Traditional

XenMatrix AB Surgical Graft

K151177 · C. R. Bard · General & Plastic Surgery

Jul 2015

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K151177 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 (Warwick, US). The FDA issued a Cleared decision on July 30, 2015, 90 days after receiving the submission on May 1, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K151177 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2015
Decision Date	July 30, 2015
Days to Decision	90 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.