# K083493: Myoscience Cryo-Touch

- Pathway: 510(k) (Traditional)
- Applicant: Myoscience, Inc.
- Decided: Mar 20, 2009 after 115 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). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 14 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 1.
- K060928: Cryoshape, Etgar Group H.M.Y.A., Ltd. (2006) Summary page 1.

## Most influential descendants
- K100447: Myoscience Cryo-Touch (2010), 10 descendants of its own
- K102021: Cryo-Touch II (2010), 9 descendants of its own
- K120415: Cryo-Touch Iii (2012), 8 descendants of its own
- K123516: Cryo-Touch IV (2013), 7 descendants of its own
- K133453: Iovera (2014), 6 descendants of its own

## Indications for use
The MyoScience Cryo-Touch device is intended to destroy tissue during surgical procedures by applying freezing cold.

Source page: https://510kreport.com/device/K083493
Methodology: https://510kreport.com/methodology