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CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K201313

by Aziyo Biologics, Inc.

Identifiers

510(k) Number
K201313 FDA 510(k)
FDA Product Code
FTM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3300 FDA 510(k)
Regulation Number
878.3300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CanGaroo Envelope is a surgical mesh device designed for subcutaneous (SubQ) placement. It is categorized as a surgical mesh under FDA classification and is intended for use in general and plastic surgery procedures. The device is structured to provide support and reinforcement to soft tissues, aiding in wound healing and structural integrity.

The CanGaroo Envelope is supplied in five sizes: small, medium, large, extra large, and extra extra large. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDD authorization. The device is intended for single-use and is not MRI-safe. Storage and handling should follow sterile medical device protocols to ensure integrity and safety prior to surgical use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aziyo Biologics, Inc.

Sources (2)

  • FDA 510(k) K201313 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026