# K262406: EluPro Antibiotic-Eluting BioEnvelope

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Aug 12, 2026 after 28 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: 12 generations back to K931386 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233991: CanGaroo RM Antibacterial Envelope, Elutia, Inc. (2024) Summary page 5.

## Indications for use
The EluPro Antibiotic-Eluting BioEnvelope 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 EluPro Antibiotic-Eluting BioEnvelope include pacemaker pulse generators, defibrillators, and other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the EluPro Antibiotic-Eluting BioEnvelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, and other neurostimulator devices. The EluPro Antibiotic-Eluting BioEnvelope 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/K262406
Methodology: https://510kreport.com/methodology