← Product Code [HBF](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF) · K875019

# GHAJAR GUIDE SYSTEM FOR THE PERFORATOR (K875019)

_Neurodynamics, Inc. · HBF · Jan 22, 1988 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K875019

## Device Facts

- **Applicant:** Neurodynamics, Inc.
- **Product Code:** [HBF](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF.md)
- **Decision Date:** Jan 22, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4305
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K875019](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K875019)

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