← Product Code [GXH](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH) · K831963

# CRYOMEDICS NEUROSTAT (K831963)

_Spembly Medical , Ltd. · GXH · Aug 12, 1983 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K831963

## Device Facts

- **Applicant:** Spembly Medical , Ltd.
- **Product Code:** [GXH](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH.md)
- **Decision Date:** Aug 12, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4250
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K831963](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K831963)

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