FDA 510(k)

Endoform Restella

K-Number: K183398 · 2019-04-11

Decision Date2019-04-11

Product CodeFTM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Endoform Restella is a medical device manufactured by Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2019-04-11 under approval 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. It is manufactured by Aroa Biosurgery , Ltd.. The 510(k) number is K183398.

When was Endoform Restella approved by the FDA?

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

What company makes Endoform Restella?

Endoform Restella is manufactured by Aroa Biosurgery , Ltd..

What is the FDA product code for Endoform Restella?

The FDA product code for Endoform Restella is FTM.

Other Devices by Aroa Biosurgery , Ltd.

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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.