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SurgiPure XD Reconstructive Tissue Matrix

by Tissue Regenix Group Plc

510(k) K152206

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152206 Date8 Mar 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FTM
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SurgiPure XD Reconstructive Tissue Matrix is a porcine-derived decellularized collagen mesh, classified as a surgical mesh under FDA category FTM. It serves as a scaffold for soft tissue repair, providing structural reinforcement during reconstructive procedures such as hernia repair or body wall defect correction. Its porous structure supports cellular infiltration, neovascularization, and collagen deposition to aid tissue regeneration.

This device is intended for surgical use only and is supplied sterile for single-use applications. It is designed for implantation by surgeons in procedures requiring reinforcement or buttressing of soft tissue. The matrix is regulated under FDA 510(k) clearance (K152206) and falls under Class II medical devices (regulation number 878.3300). Multiple registration numbers and FEI numbers are associated with its distribution for soft tissue repair in general and plastic surgery applications.