Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4440](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4440) → HBM — Headrest, Neurosurgical

# HBM · Headrest, Neurosurgical

_Neurology · 21 CFR 882.4440 · Class 1_

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

## Overview

- **Product Code:** HBM
- **Device Name:** Headrest, Neurosurgical
- **Regulation:** [21 CFR 882.4440](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4440)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A neurosurgical headrest is a device used to support the patient's head during a surgical procedure.

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K911918](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBM/K911918.md) | SWIVEL HORSESHOE HEADREST | Codman & Shurtleff, Inc. | Jul 17, 1991 | SESE |
| [K911917](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBM/K911917.md) | CODMAN PEDIATRIC HORSESHOE HEADREST | Codman & Shurtleff, Inc. | Jul 17, 1991 | SESE |
| [K822169](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBM/K822169.md) | SURGICAL HEAD SUPPORT | Kelleher Corp. | Aug 20, 1982 | SESE |

## Top Applicants

- Codman & Shurtleff, Inc. — 2 clearances
- Kelleher Corp. — 1 clearance

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

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