# K060928: Cryoshape

- Pathway: 510(k) (Traditional)
- Applicant: Etgar Group H.M.Y.A., Ltd.
- Decided: May 22, 2006 after 48 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
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cryoprobe: named in the summary without a submission number

## Most influential descendants
- K083493: Myoscience Cryo-Touch (2009), 11 descendants of its own
- 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

## Indications for use
The CryoShape is intended to destroy tissue during surgical procedures by applying extreme cold.

Source page: https://510kreport.com/device/K060928
Methodology: https://510kreport.com/methodology