# K131007: Aigis RX N Medium; Aigis RX N Large

- Pathway: 510(k) (Traditional)
- Applicant: Tyrx, Inc.
- Decided: Jul 10, 2013 after 90 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: 8 generations back to K931386 (1993). 19 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063091: Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601, Tyrx Pharma, Inc. (2008) Summary page 1.

## Most influential descendants
- K132699: Aigis RX N (Medium), Aigis RX N (Large) (2013), 5 descendants of its own
- K142611: TYRX Neuro Absorbable Antibacterial Envelope (2014), 4 descendants of its own
- K150291: TYRX Neuro Absorbable Antibacterial Envelope (2015), 3 descendants of its own
- K180122: TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) (2018), 1 descendant of its own
- K192636: TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) (2020), 0 descendants of its own

## Indications for use
AIGISRx® N is intended to hold a vagus nerve stimulator securely in order to create a stable environment when implanted in the body. AIGISRx® N 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 or defibrillator. This device is only intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa.

Source page: https://510kreport.com/device/K131007
Methodology: https://510kreport.com/methodology