# K031482: Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe, C) Cryostar 2MM Cryoprobe, D) Convenience

- Pathway: 510(k) (Traditional)
- Applicant: Cryomedical Instruemts, Ltd.
- Decided: Jul 10, 2003 after 59 days
- Product code: GXH (Device, Surgical, Cryogenic)
- Device class: 2
- Regulation: 21 CFR 882.4250
- 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 K781302 (1978). 3 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781302: Neurostat, Lloyd, Spembly Medical, Ltd. (1978) Summary page 1.
- K831963: Cryomedics Neurostat, Spembly Medical, Ltd. (1983) Summary page 1.
- K854334: Painblocker WA5000, Wallach Surgical Devices, Inc. (1986) Summary page 1.

## Most influential descendants
- K050272: Cryomedical Instruments Cryo-Pac Systems (2005), 11 descendants of its own
- K100447: Myoscience Cryo-Touch (2010), 10 descendants of its own
- K142203: Atricure Cryo Module System; cryoICE cryoablation probe (2014), 9 descendants of its own
- K102021: Cryo-Touch II (2010), 9 descendants of its own
- K120415: Cryo-Touch Iii (2012), 8 descendants of its own

## Indications for use
The CryoStar™ system is a cryoanalgesia device intended for use in blocking pain by temporarily ablating the peripheral nerves.

Source page: https://510kreport.com/device/K031482
Methodology: https://510kreport.com/methodology