Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4950](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4950) → FWX — Table, Operating-Room, Mechanical

# FWX · Table, Operating-Room, Mechanical

_General, Plastic Surgery · 21 CFR 878.4950 · Class 1_

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

## Overview

- **Product Code:** FWX
- **Device Name:** Table, Operating-Room, Mechanical
- **Regulation:** [21 CFR 878.4950](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4950)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

## 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 § 878.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K884019](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWX/K884019.md) | ALM OPERATING TABLES | Alm Surgical Equipment, Inc. | Oct 13, 1988 | SESE |
| [K841116](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWX/K841116.md) | MOBILE OPHTHALMIC OPERATING TABLE | Surgi-Quip Inc.U | May 9, 1984 | SESE |
| [K821923](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWX/K821923.md) | TABLE, OPERATING, FIELD 6530-00-709-8175 | Emerson-Sack-Warner Corp. | Jul 13, 1982 | SESE |

## Top Applicants

- Alm Surgical Equipment, Inc. — 1 clearance
- Emerson-Sack-Warner Corp. — 1 clearance
- Surgi-Quip Inc.U — 1 clearance

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

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