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) → FWY — Table, Operating-Room, Non-Electrical

# FWY · Table, Operating-Room, Non-Electrical

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

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

## Overview

- **Product Code:** FWY
- **Device Name:** Table, Operating-Room, Non-Electrical
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K883457](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWY/K883457.md) | ASST-3000 SPINAL SURGERY TABLE | Orthopedic Systems, Inc. | Aug 26, 1988 | SESE |
| [K873478](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWY/K873478.md) | SKYTRON MODEL 130 SURGICAL TABLE | Skytron, Div. the Kmw Group, Inc. | Sep 24, 1987 | SESE |
| [K833509](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWY/K833509.md) | CHEMONUCLEOLYSIS TABLE | Stryker Corp. | Nov 28, 1983 | SESE |
| [K800118](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWY/K800118.md) | CHICK SURGICAL TABLE | Warner-Lambert Co. | Feb 5, 1980 | SESE |

## Top Applicants

- Orthopedic Systems, Inc. — 1 clearance
- Skytron, Div. the Kmw Group, Inc. — 1 clearance
- Stryker Corp. — 1 clearance
- Warner-Lambert Co. — 1 clearance

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

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