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) → FWW — Table, Operating-Room, Pneumatic

# FWW · Table, Operating-Room, Pneumatic

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

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

## Overview

- **Product Code:** FWW
- **Device Name:** Table, Operating-Room, Pneumatic
- **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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K953961](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWW/K953961.md) | OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM | Osteonics Corp. | Nov 29, 1995 | SESE |
| [K935356](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWW/K935356.md) | CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES | Amsco American Sterilizer Co. | Mar 23, 1994 | SESE |
| [K931876](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWW/K931876.md) | FISK ARM SUPPORT | Vvortex International Corp. | Sep 9, 1993 | SESE |
| [K924713](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWW/K924713.md) | UNIVERSAL SURGICAL INSTRUMENT HOLDER | T. Korossurgical Instruments Corp. | May 17, 1993 | SESE |
| [K863161](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWW/K863161.md) | TABLE, OPERATING ROOM, HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | Sep 5, 1986 | SESE |
| [K853479](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWW/K853479.md) | SKYTRON ELITE 300 SURGERY TABLE | Skytron, Div. the Kmw Group, Inc. | Sep 5, 1985 | SESE |

## Top Applicants

- Amsco American Sterilizer Co. — 1 clearance
- Kamiya Tsusan Kaisha, Ltd. — 1 clearance
- Osteonics Corp. — 1 clearance
- Skytron, Div. the Kmw Group, Inc. — 1 clearance
- T. Korossurgical Instruments Corp. — 1 clearance

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

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