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FDA 510(k)

Endoform Restella

K-Number: K183398 · 2019-04-11

ApplicantAroa Biosurgery , Ltd.
Decision Date2019-04-11
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Endoform Restella 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 2019-04-11 under 510(k) number K183398. 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 Restella?

Endoform Restella is a medical device that received FDA 510(k) clearance on 2019-04-11. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K183398.

When did Endoform Restella receive FDA 510(k) clearance?

Endoform Restella received FDA 510(k) clearance on 2019-04-11, under 510(k) number K183398.

Who is the listed applicant for Endoform Restella?

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 Restella?

The FDA product code for Endoform Restella 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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