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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 the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regenix Group Plc. It received FDA 510(k) clearance on 2016-03-08 under 510(k) 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. The listed applicant is Tissue Regenix Group Plc. The 510(k) number is K152206.

When did SurgiPure XD Reconstructive Tissue Matrix receive FDA 510(k) clearance?

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

Who is the listed applicant for SurgiPure XD Reconstructive Tissue Matrix?

The FDA 510(k) record lists Tissue Regenix Group Plc as the applicant. This does not by itself establish the device manufacturer.

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

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NCT06575192Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult ParticipantsRECRUITING

Related Devices (Code: FTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.

Official Source

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

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