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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 the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2025-06-03 under 510(k) 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. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K250598.

When did Endoform Reconstructive Template - PLGA receive FDA 510(k) clearance?

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

Who is the listed applicant for Endoform Reconstructive Template - PLGA?

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

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)

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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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