Cleared Special

XENMATRIX SURGICAL GRAFT

K140501 · C. R. Bard · General & Plastic Surgery
Apr 2014
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K140501 is an FDA 510(k) clearance for the XENMATRIX SURGICAL GRAFT, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by C. R. Bard (Warwick, US). The FDA issued a Cleared decision on April 28, 2014, 60 days after receiving the submission on February 27, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K140501 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2014
Decision Date April 28, 2014
Days to Decision 60 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTM — Mesh, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300

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