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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 the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery (Formerly Mesynthes Limited). It received FDA 510(k) clearance on 2016-12-20 under 510(k) 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. The listed applicant is Aroa Biosurgery (Formerly Mesynthes Limited). The 510(k) number is K162461.

When did Endoform Plastics and Reconstructive Matrix receive FDA 510(k) clearance?

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

Who is the listed applicant for Endoform Plastics and Reconstructive Matrix?

The FDA 510(k) record lists Aroa Biosurgery (Formerly Mesynthes Limited) as the applicant. This does not by itself establish the device manufacturer.

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 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.

K250598Endoform 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.K214070OviTex PRS (Long Term Resorbable)Tela Bio

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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