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FDA 510(k)

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)

K-Number: K201313 · 2020-06-15

ApplicantAziyo Biologics, Inc.
Decision Date2020-06-15
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) is a medical device manufactured by Aziyo Biologics, Inc.. It received FDA 510(k) clearance on 2020-06-15 under approval number K201313. 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 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)?

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) is a medical device that received FDA 510(k) clearance on 2020-06-15. It is manufactured by Aziyo Biologics, Inc.. The 510(k) number is K201313.

When was CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) approved by the FDA?

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) received FDA 510(k) clearance on 2020-06-15, under approval number K201313.

What company makes CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)?

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) is manufactured by Aziyo Biologics, Inc..

What is the FDA product code for CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)?

The FDA product code for CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) is FTM.

Related Clinical Trials

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Related PubMed Literature

PMID: 41302949 Postmarketing Surveillance of Thrombectomy Using a Tron FX Stent Retriever for Large and Medium Vessel Occlusion. Journal of clinical medicine (2025) PMID: 41123878 Medical devices in Europe, all but drugs: time to radically change their regulation? Internal and emergency medicine (2026)

Other Devices by Aziyo Biologics, Inc.

K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)

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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