Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4125](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4125) → HBN — Chair, Neurosurgical

# HBN · Chair, Neurosurgical

_Neurology · 21 CFR 882.4125 · Class 1_

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

## Overview

- **Product Code:** HBN
- **Device Name:** Chair, Neurosurgical
- **Regulation:** [21 CFR 882.4125](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4125)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A neurosurgical chair is an operating room chair used to position and support a patient during neurosurgery.

## 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K900472](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBN/K900472.md) | SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI | Skytron, Div. the Kmw Group, Inc. | Sep 4, 1990 | SESE |
| [K822428](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBN/K822428.md) | SURGI-QUIP MICROSCOPE STAND | Surgi-Quip Inc.U | Sep 2, 1982 | SESE |
| [K822426](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBN/K822426.md) | MCINTYRE MICROSCOPE STAND | Surgi-Quip Inc.U | Sep 2, 1982 | SESE |
| [K822012](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBN/K822012.md) | BINOCULAR OPERATING MICROSCOPES & | Kelleher Corp. | Jul 30, 1982 | SESE |

## Top Applicants

- Surgi-Quip Inc.U — 2 clearances
- Kelleher Corp. — 1 clearance
- Skytron, Div. the Kmw Group, Inc. — 1 clearance

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

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