# K062478: Clavis

- Pathway: 510(k) (Abbreviated)
- Applicant: Medtronic A/S
- Decided: Feb 8, 2007 after 168 days
- Product code: BXN (Stimulator, Nerve, Battery-Powered)
- Device class: 2
- Regulation: 21 CFR 868.2775
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111985: Myoguide System Model 8008 (2011), 0 descendants of its own

## Indications for use
CLAVISTM is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.

Source page: https://510kreport.com/device/K062478
Methodology: https://510kreport.com/methodology