← Product Code [GXH](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH) · K854334

# PAINBLOCKER WA5000 (K854334)

_Wallach Surgical Devices, Inc. · GXH · Apr 30, 1986 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K854334

## Device Facts

- **Applicant:** Wallach Surgical Devices, Inc.
- **Product Code:** [GXH](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH.md)
- **Decision Date:** Apr 30, 1986
- **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/K854334](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K854334)

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