# K173242: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)

- Pathway: 510(k) (Special)
- Applicant: Aziyo Biologics, Inc.
- Decided: Oct 25, 2017 after 19 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K842066 (1985). 82 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140306: Cormatrix Protect Ecm Envelope, Cormatrix Cardiovascular, Inc. (2014) Summary page 4.

## Most influential descendants
- K182255: CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (2018), 2 descendants of its own
- K192616: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) (2019), 1 descendant of its own
- K201313: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) (2020), 0 descendants of its own

## Recalls of this device
- Aug 21, 2019 · Class II · Z-0040-2020: Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.

## Indications for use
The CanGaroo(R) Envelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.

Source page: https://510kreport.com/device/K173242
Methodology: https://510kreport.com/methodology