# K200764: Statstix

- Pathway: 510(k) (Traditional)
- Applicant: Centrix Incorporated
- Decided: Oct 15, 2020 after 205 days
- Product code: MVL (Cord, Retraction)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K093711 (2010). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193389: Vista Clear, Inter-Med/Vista Dental Products (2020) Summary page 4.

## Indications for use
StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.

Source page: https://510kreport.com/device/K200764
Methodology: https://510kreport.com/methodology