# K161615: Accurett

- Pathway: 510(k) (Special)
- Applicant: H&O Equipments, Nv/Sa
- Decided: Aug 23, 2016 after 74 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K024009 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024009: Cryoprobe, H&O Equipments, Nv/Sa (2003) Summary page 4.

## Indications for use
To destroy tissue during surgical procedures by applying extreme cold.

Source page: https://510kreport.com/device/K161615
Methodology: https://510kreport.com/methodology