# K123516: Cryo-Touch IV

- Pathway: 510(k) (Traditional)
- Applicant: Myoscience, Inc.
- Decided: Jan 10, 2013 after 57 days
- Product code: GXH (Device, Surgical, Cryogenic)
- Device class: 2
- Regulation: 21 CFR 882.4250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K781302 (1978). 11 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102021: Cryo-Touch II, Myoscience, Inc. (2010) Summary page 1.
- K120415: Cryo-Touch Iii, Myoscience, Inc. (2012) Summary page 1.

## Most influential descendants
- K133453: Iovera (2014), 6 descendants of its own
- K142866: Myoscience iovera system (2015), 5 descendants of its own
- K161835: iovera system (2017), 4 descendants of its own
- K211334: Iovera System (2021), 2 descendants of its own
- K173763: iovera system (2018), 2 descendants of its own

## Recalls of this device
- Jun 21, 2013 · Class II · Z-1781-2013: The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (US

## Indications for use
The Myoscience Cryo-Touch IV is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV is not indicated for treatment of central nervous system tissue.

Source page: https://510kreport.com/device/K123516
Methodology: https://510kreport.com/methodology