# K233991: CanGaroo RM Antibacterial Envelope

- Pathway: 510(k) (Traditional)
- Applicant: Elutia, Inc.
- Decided: Jun 14, 2024 after 179 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931386 (1993). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192389: TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large), Medtronic, Inc. (2020) Summary page 4.

## Most influential descendants
- K262406: EluPro Antibiotic-Eluting BioEnvelope (2026), 0 descendants of its own

## Indications for use
The CanGaroo® RM Antibacterial 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 RM Antibacterial Envelope include pacemaker pulse generators, defibrillators, and other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo RM Antibacterial Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, and other neurostimulator devices. The CanGaroo RM Antibacterial Envelope contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope. Overall clinical benefit has not yet been evaluated.

Source page: https://510kreport.com/device/K233991
Methodology: https://510kreport.com/methodology