Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4845](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4845) → HAD — Rongeur, Powered

# HAD · Rongeur, Powered

_Neurology · 21 CFR 882.4845 · Class 2_

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

## Overview

- **Product Code:** HAD
- **Device Name:** Rongeur, Powered
- **Regulation:** [21 CFR 882.4845](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4845)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K062413](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAD/K062413.md) | AESCULAP PNEUMATIC KERRISON | Aesculap, Inc. | Nov 21, 2006 | SESE |
| [K022907](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAD/K022907.md) | ANSPACH POWERED KERRISON SYSTEM (PKS) | The Anspach Effort, Inc. | Oct 21, 2002 | SESE |
| [K911637](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAD/K911637.md) | STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD | Personal Products Co. | Aug 2, 1991 | SESE |

## Top Applicants

- Aesculap, Inc. — 1 clearance
- Personal Products Co. — 1 clearance
- The Anspach Effort, Inc. — 1 clearance

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

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