Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4960](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4960) → GBB — Chair, Surgical, Ac-Powered

# GBB · Chair, Surgical, Ac-Powered

_General, Plastic Surgery · 21 CFR 878.4960 · Class 1_

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

## Overview

- **Product Code:** GBB
- **Device Name:** Chair, Surgical, Ac-Powered
- **Regulation:** [21 CFR 878.4960](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4960)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

## 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 § 878.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K964102](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBB/K964102.md) | TENET TIBIAL FRACTURE SUPPORT | Tenet Medical Engineering | Dec 5, 1996 | SESE |
| [K893598](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBB/K893598.md) | HYDRAULIC FOOT OPERATED STOOL | Arthro-Medic, Inc. | Oct 10, 1989 | SESE |
| [K831385](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBB/K831385.md) | LITHOTOMY CHAIR #415 | Midmark Corp. | Jun 2, 1983 | SESE |
| [K831325](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBB/K831325.md) | NUTROMAT | Medlog GmbH Marketing Services | Jun 2, 1983 | SESE |
| [K822264](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBB/K822264.md) | NAGASHIMA SN OPERATOR'S CHAIR | Kelleher Corp. | Oct 13, 1982 | SESE |
| [K822251](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBB/K822251.md) | EXAMINATION & TREATMENT CHAIRS | Kelleher Corp. | Aug 27, 1982 | SESE |
| [K822013](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBB/K822013.md) | NAGASHIMA SN AUTOMATIC TREATMENT CHAIR | Kelleher Corp. | Jul 28, 1982 | SESE |
| [K820636](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBB/K820636.md) | STORZ #6500 POWER EXAMINATION CHAIR | Storz Instrument Co. | Mar 26, 1982 | SESE |

## Top Applicants

- Kelleher Corp. — 3 clearances
- Arthro-Medic, Inc. — 1 clearance
- Medlog GmbH Marketing Services — 1 clearance
- Midmark Corp. — 1 clearance
- Storz Instrument Co. — 1 clearance

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

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