CanGaroo Envelope (small), (medium), (large), (extra large)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173242 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 pouch classified as a Mesh, Surgical device. It is designed to encase cardiac implantable electronic devices (CIEDs), such as pacemakers or defibrillators, providing a protective barrier to stabilize their positioning within the body.
Constructed from two perforated, 4-ply sheets of decellularized, non-crosslinked, lyophilized porcine small intestinal submucosa (ECM), the device is intended for single-use in surgical settings. Authorized under FDA 510K and MDD compliance, it is supplied sterile and requires no additional preparation beyond standard surgical aseptic techniques. Available in four sizes—small, medium, large, and extra large—it is intended for use in cardiac and neurostimulation procedures.
Frequently asked questions
What is the CanGaroo Envelope designed to protect and how does it achieve this?
The CanGaroo Envelope is specifically designed to encase cardiac implantable electronic devices (CIEDs), such as pacemakers or defibrillators. It provides a protective barrier to stabilize their positioning within the body, reducing the risk of displacement or irritation from surrounding tissues. The envelope is made from two perforated sheets of decellularized porcine small intestinal submucosa (ECM), which creates a flexible yet supportive pouch that cradles the device securely during and after implantation.
Are the CanGaroo Envelopes reusable or intended for single-use, and what does this mean for surgical workflows?
The CanGaroo Envelopes are explicitly intended for single-use only in surgical settings. This means each envelope is sterile, pre-packaged, and designed to be opened and used once before disposal. For surgical workflows, this eliminates the need for cleaning, sterilization, or reprocessing between cases, streamlining procedures and ensuring consistent sterility per standard surgical aseptic techniques.
What sizes are available for the CanGaroo Envelope, and how do I determine which size to use for a patient?
The CanGaroo Envelope comes in four sizes: small, medium, large, and extra large. The appropriate size should be selected based on the dimensions of the specific CIED being implanted, ensuring a snug yet non-constrictive fit around the device. The manufacturer’s sizing guidelines (likely included in the packaging or surgical instructions) should be consulted to match the envelope to the device’s dimensions for optimal stabilization and protection.
How should the CanGaroo Envelope be stored, and what precautions should be taken to maintain its sterility?
The CanGaroo Envelope is supplied sterile and should be stored according to the manufacturer’s instructions, typically in its original, sealed packaging until ready for use. It requires no additional preparation beyond adhering to standard surgical aseptic techniques during opening and implantation. Avoid exposing the envelope to moisture, contamination, or prolonged storage outside the recommended conditions to preserve sterility and integrity.
What regulatory pathways have the CanGaroo Envelope followed, and what does this mean for clinicians or purchasers?
The CanGaroo Envelope has been authorized under FDA 510(k) clearance and complies with the MDD (Medical Device Directive). This means the device has undergone regulatory review to demonstrate substantial equivalence to legally marketed predicate devices and meets safety and performance requirements for its intended use. Clinicians and purchasers can rely on this authorization as evidence of the device’s compliance with applicable regulations, though local healthcare regulations may still apply.
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. Sources consulted: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo ..., CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo ..., PDF K173242 - CanGaroo Envelope (small), CanGaroo Envelope (medium ..., CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173242 | Class II | Active |
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Manufacturer
- Manufacturer
- Aziyo Biologics, Inc.
Sources (2)
- FDA 510(k) K173242 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026