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FDA 510(k)

Endoform Reconstructive Template - Non Absorbable

K-Number: K181935 · 2018-12-04

ApplicantAroa Biosurgery , Ltd.
Decision Date2018-12-04
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Endoform Reconstructive Template - Non Absorbable is a medical device manufactured by Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2018-12-04 under approval number K181935. 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 - Non Absorbable?

Endoform Reconstructive Template - Non Absorbable is a medical device that received FDA 510(k) clearance on 2018-12-04. It is manufactured by Aroa Biosurgery , Ltd.. The 510(k) number is K181935.

When was Endoform Reconstructive Template - Non Absorbable approved by the FDA?

Endoform Reconstructive Template - Non Absorbable received FDA 510(k) clearance on 2018-12-04, under approval number K181935.

What company makes Endoform Reconstructive Template - Non Absorbable?

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

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

The FDA product code for Endoform Reconstructive Template - Non Absorbable is FTL.

Other Devices by Aroa Biosurgery , Ltd.

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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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