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FDA 510(k)

Endoform Reconstructive Template

K-Number: K153632 · 2016-06-16

ApplicantAroa Biosurgery Limited (Formerly Mesynthes Limited)
Decision Date2016-06-16
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Endoform Reconstructive Template is a medical device manufactured by Aroa Biosurgery Limited (Formerly Mesynthes Limited). It received FDA 510(k) clearance on 2016-06-16 under approval number K153632. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoform Reconstructive Template?

Endoform Reconstructive Template is a medical device that received FDA 510(k) clearance on 2016-06-16. It is manufactured by Aroa Biosurgery Limited (Formerly Mesynthes Limited). The 510(k) number is K153632.

When was Endoform Reconstructive Template approved by the FDA?

Endoform Reconstructive Template received FDA 510(k) clearance on 2016-06-16, under approval number K153632.

What company makes Endoform Reconstructive Template?

Endoform Reconstructive Template is manufactured by Aroa Biosurgery Limited (Formerly Mesynthes Limited).

What is the FDA product code for Endoform Reconstructive Template?

The FDA product code for Endoform Reconstructive Template is FTL.

Other Devices by Aroa Biosurgery Limited (Formerly Mesynthes Limited)

K153633Endoform Reconstructive Template

Related Devices (Code: FTL)

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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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