# K182255: CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)

- Pathway: 510(k) (Traditional)
- Applicant: Aziyo Biologics, Inc.
- Decided: Nov 15, 2018 after 87 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: 12 generations back to K842066 (1985). 83 ancestors in all.
2 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)
- K173242: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), Aziyo Biologics, Inc. (2017) Summary page 4.

## Most influential descendants
- 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 or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

Source page: https://510kreport.com/device/K182255
Methodology: https://510kreport.com/methodology