Cleared Special

SurgiMend PRS Meshed, Revize-X

K171357 · Integra Lifesciences Corporation (Owner of Tei Biosciences) · General & Plastic Surgery
Jun 2017
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K171357 is an FDA 510(k) clearance for the SurgiMend PRS Meshed, Revize-X, a Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery (Class II — Special Controls, product code OXH), submitted by Integra Lifesciences Corporation (Owner of Tei Biosciences) (Boston, US). The FDA issued a Cleared decision on June 7, 2017, 29 days after receiving the submission on May 9, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K171357 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2017
Decision Date June 07, 2017
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OXH — Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.