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) → FQO — Table, Operating-Room, Ac-Powered

# FQO · Table, Operating-Room, 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/FQO

## Overview

- **Product Code:** FQO
- **Device Name:** Table, Operating-Room, 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 (20 of 35)

Showing 20 most recent of 35 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K240598](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K240598.md) | Maestro System (REF100) | Moon Surgical | Jun 3, 2024 | SESE |
| [K221410](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K221410.md) | Maestro Platform | Moon Surgical | Dec 2, 2022 | SESE |
| [K090136](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K090136.md) | STERIS CMAX XLT SURGICAL TABLE | STERIS Corporation | Mar 20, 2009 | SESE |
| [K972810](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K972810.md) | OPT80 THE TRANSPORTABLE (OPT80) | O.P.T. USA, Inc. | Aug 26, 1997 | SESE |
| [K971988](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K971988.md) | ALLEN, ULTRA AND SMART SOCKETS | Allen Medical Systems, Inc. | Jul 11, 1997 | SESE |
| [K971307](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K971307.md) | AMSCO SURGICAL TABLE | STERIS Corporation | Jun 27, 1997 | SESE |
| [K963506](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K963506.md) | TENET RADIOLUCENT HAND TABLE | Tenet Medical Engineering | Jan 9, 1997 | SESE |
| [K961886](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K961886.md) | DRAGER GEMINA WALL-MOUNTED WORKPLACE | Alm Surgical Equipment, Inc. | Jul 30, 1996 | SESE |
| [K961742](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K961742.md) | DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM | Alm Surgical Equipment, Inc. | Jul 26, 1996 | SESE |
| [K955750](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K955750.md) | TELETOM | Berchtold Holding GmbH | Feb 8, 1996 | SESE |
| [K953980](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K953980.md) | KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT | Kreuzer Corp. | Nov 16, 1995 | SESE |
| [K951854](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K951854.md) | LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY | Leonard Medical, Inc. | Jun 21, 1995 | SESE |
| [K950192](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K950192.md) | SKYTRON SKYBOOM SERIES | Skytron, Div. the Kmw Group, Inc. | Apr 3, 1995 | SESE |
| [K926463](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K926463.md) | RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES | Midmark Corp. | Oct 21, 1994 | SESE |
| [K942486](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K942486.md) | IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE | Mdt Corp., Inc. | Aug 10, 1994 | SESE |
| [K942043](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K942043.md) | DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E | Alm Surgical Equipment, Inc. | Jul 13, 1994 | SESE |
| [K941150](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K941150.md) | MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES | Mdt Technology For Life | Jun 10, 1994 | SESE |
| [K940068](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K940068.md) | STRYKER OPERATING ROOM TABLE | Stryker Medical | May 5, 1994 | SESE |
| [K936308](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K936308.md) | ENDEX ENDOSCOPIC POSITIONING SYSTEM | Andronic Devices, Ltd. | Mar 31, 1994 | SESE |
| [K926525](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQO/K926525.md) | BETASTAR 1131.02 MOBILE OPERATING TABLE | Stierlen-Maquet AG | Oct 12, 1993 | SESE |

## Top Applicants

- Alm Surgical Equipment, Inc. — 4 clearances
- American Sterilizer Co. — 2 clearances
- Andronic Devices, Ltd. — 2 clearances
- Berchtold Holding GmbH — 2 clearances
- Koken Mfg Company, Inc. — 2 clearances

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

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