Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SurgiPure XD Reconstructive Tissue Matrix

K-Number: K152206 · 2016-03-08

ApplicantTissue Regenix Group Plc
Decision Date2016-03-08
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SurgiPure XD Reconstructive Tissue Matrix is a medical device manufactured by Tissue Regenix Group Plc. It received FDA 510(k) clearance on 2016-03-08 under approval number K152206. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiPure XD Reconstructive Tissue Matrix?

SurgiPure XD Reconstructive Tissue Matrix is a medical device that received FDA 510(k) clearance on 2016-03-08. It is manufactured by Tissue Regenix Group Plc. The 510(k) number is K152206.

When was SurgiPure XD Reconstructive Tissue Matrix approved by the FDA?

SurgiPure XD Reconstructive Tissue Matrix received FDA 510(k) clearance on 2016-03-08, under approval number K152206.

What company makes SurgiPure XD Reconstructive Tissue Matrix?

SurgiPure XD Reconstructive Tissue Matrix is manufactured by Tissue Regenix Group Plc.

What is the FDA product code for SurgiPure XD Reconstructive Tissue Matrix?

The FDA product code for SurgiPure XD Reconstructive Tissue Matrix is FTM.

Related Clinical Trials

NCT07431099 Skin Color Matching in Head and Neck Reconstructive Surgery RECRUITING NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 41972695 Glycerol-Based Cryopreservation of CELT-Fat: Identification of the Optimal Concentration in a GMP-Compatible Protocol. Cells (2026) PMID: 40001655 Towards Safety and Regulation Criteria for Clinical Applications of Decellularized Organ-Derived Matrices. Bioengineering (Basel, Switzerland) (2025)

Related Devices (Code: FTM)

K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited) K162554Gentrix Surgical MatrixAcell, Inc. K160181COLORADO THERAPEUTICS XENOGRAFT IMPLANTColorado Therapeutics, LLC K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑