Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4310](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4310) → NLN — Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed

# NLN · Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed

_Neurology · 21 CFR 882.4310 · Class 2_

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

## Overview

- **Product Code:** NLN
- **Device Name:** Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
- **Regulation:** [21 CFR 882.4310](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4310)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K041978](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/NLN/K041978.md) | REPROCESSED DIAMOND BURS | Alliance Medical Corp. | Nov 23, 2004 | SESE |

## Top Applicants

- Alliance Medical Corp. — 1 clearance

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

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