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FDA 510(k)

Endoform Plastics and Reconstructive Matrix

K-Number: K162461 · 2016-12-20

ApplicantAroa Biosurgery (Formerly Mesynthes Limited)
Decision Date2016-12-20
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Endoform Plastics and Reconstructive Matrix is a medical device manufactured by Aroa Biosurgery (Formerly Mesynthes Limited). It received FDA 510(k) clearance on 2016-12-20 under approval number K162461. 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 Endoform Plastics and Reconstructive Matrix?

Endoform Plastics and Reconstructive Matrix is a medical device that received FDA 510(k) clearance on 2016-12-20. It is manufactured by Aroa Biosurgery (Formerly Mesynthes Limited). The 510(k) number is K162461.

When was Endoform Plastics and Reconstructive Matrix approved by the FDA?

Endoform Plastics and Reconstructive Matrix received FDA 510(k) clearance on 2016-12-20, under approval number K162461.

What company makes Endoform Plastics and Reconstructive Matrix?

Endoform Plastics and Reconstructive Matrix is manufactured by Aroa Biosurgery (Formerly Mesynthes Limited).

What is the FDA product code for Endoform Plastics and Reconstructive Matrix?

The FDA product code for Endoform Plastics and Reconstructive Matrix is FTM.

Related Clinical Trials

NCT06511167 Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery RECRUITING

Related Devices (Code: FTM)

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) K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc

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.

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