# K152678: TYRX Neuro Antibacterial Envelope

- Pathway: 510(k) (Traditional)
- Applicant: Tyrx, Inc.
- Decided: Nov 17, 2015 after 60 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132699: Aigis RX N (Medium), Aigis RX N (Large), Tyrx, Inc. (2013) Summary page 5.
- K150291: TYRX Neuro Absorbable Antibacterial Envelope, Medtronic Tyrx, Inc. (2015) Summary page 5.

## Indications for use
TYRX Neuro Non-Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator securely in order to create a stable environment when implanted in the body. TYRX Neuro Non-Absorbable Antibacterial Envelope contains the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators or deep brain stimulators implanted in the infraclavicular fossa, or in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region. TYRX Neuro Non-Absorbable Antibacterial Envelope is intended for single-patient, one-time use only.

Source page: https://510kreport.com/device/K152678
Methodology: https://510kreport.com/methodology