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FDA 510(k)

Endoform Reconstructive Template - PLGA

K-Number: K250598 · 2025-06-03

ApplicantAroa Biosurgery , Ltd.
Decision Date2025-06-03
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Endoform Reconstructive Template - PLGA is a medical device manufactured by Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2025-06-03 under approval number K250598. 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 Reconstructive Template - PLGA?

Endoform Reconstructive Template - PLGA is a medical device that received FDA 510(k) clearance on 2025-06-03. It is manufactured by Aroa Biosurgery , Ltd.. The 510(k) number is K250598.

When was Endoform Reconstructive Template - PLGA approved by the FDA?

Endoform Reconstructive Template - PLGA received FDA 510(k) clearance on 2025-06-03, under approval number K250598.

What company makes Endoform Reconstructive Template - PLGA?

Endoform Reconstructive Template - PLGA is manufactured by Aroa Biosurgery , Ltd..

What is the FDA product code for Endoform Reconstructive Template - PLGA?

The FDA product code for Endoform Reconstructive Template - PLGA is FTM.

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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.

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