Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4325](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4325) → HBD — Handpiece (Brace), Drill

# HBD · Handpiece (Brace), Drill

_Neurology · 21 CFR 882.4325 · Class 1_

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

## Overview

- **Product Code:** HBD
- **Device Name:** Handpiece (Brace), Drill
- **Regulation:** [21 CFR 882.4325](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4325)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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