CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192616 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, designed to encase and secure cardiac implantable electronic devices (CIEDs) such as pacemakers, defibrillators, or implantable neurostimulators. Constructed from an acellular biomatrix derived from porcine small intestine submucosa (SIS ECM), it provides a protective barrier to stabilize the device post-implantation. Its perforated, multi-ply structure facilitates tissue integration while maintaining device integrity.
Available in five sizes—small, medium, large, extra large, and extra extra large—the CanGaroo Envelope is intended for subcutaneous (SubQ) use. Supplied sterile and intended for single-use, it is regulated under FDA 510(k) clearance (K192616) as a Class II device. Compliance with FDA requirements ensures its suitability for use in general and plastic surgery procedures, though its primary application remains in cardiac and neurostimulation implant settings. Storage and handling follow standard sterile surgical protocols.
Frequently asked questions
What types of cardiac implantable electronic devices (CIEDs) is the CanGaroo Envelope designed to encase and protect?
The CanGaroo Envelope is specifically designed to encase and secure cardiac implantable electronic devices (CIEDs) such as pacemakers, defibrillators, and implantable neurostimulators. Its perforated, multi-ply structure provides a protective barrier to stabilize the device post-implantation while promoting tissue integration.
How many sizes of the CanGaroo Envelope are available, and what are the differences between them?
The CanGaroo Envelope is available in five sizes: small, medium, large, extra large, and extra extra large. These sizes accommodate varying device sizes and patient anatomies, ensuring proper coverage and stabilization of the implanted CIED while maintaining compatibility with subcutaneous (SubQ) placement.
Is the CanGaroo Envelope intended for single-use or reusable applications, and how should it be stored?
The CanGaroo Envelope is supplied sterile and intended for single-use only. It must be stored following standard sterile surgical protocols to maintain its integrity and sterility before use, ensuring compliance with medical device handling guidelines.
What material is the CanGaroo Envelope made from, and how does it support tissue integration?
The CanGaroo Envelope is constructed from an acellular biomatrix derived from porcine small intestine submucosa (SIS ECM). This material facilitates tissue integration through its perforated, multi-ply design, allowing surrounding tissues to grow into the mesh while maintaining the structural integrity of the encased CIED.
What regulatory pathway does the CanGaroo Envelope follow, and what does this mean for its use in clinical settings?
The CanGaroo Envelope is regulated under FDA 510(k) clearance (K192616) as a Class II device, classified under product code FTM (Mesh, Surgical). This clearance indicates it has been deemed substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for use in cardiac and neurostimulation implant procedures, though its primary application remains in CIED stabilization.
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 - Boston Scientific, CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo ..., CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192616 | Class II | Active |
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Manufacturer
- Manufacturer
- Aziyo Biologics, Inc.
Sources (1)
- FDA 510(k) K192616 24 fields · synced Sep 20, 2026