Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4300](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4300) → NLO — Drills, Burrs, Trephines And Accessories (Manual), Reprocessed

# NLO · Drills, Burrs, Trephines And Accessories (Manual), Reprocessed

_Neurology · 21 CFR 882.4300 · Class 2_

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

## Overview

- **Product Code:** NLO
- **Device Name:** Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
- **Regulation:** [21 CFR 882.4300](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4300)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.

## Classification Rationale

Class II (performance standards).

## 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/NLO](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/NLO)

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