FQO · Table, Operating-Room, Ac-Powered
General, Plastic Surgery · 21 CFR 878.4960 · Class 1
Overview
| Product Code | FQO |
|---|---|
| Device Name | Table, Operating-Room, Ac-Powered |
| Regulation | 21 CFR 878.4960 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
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 | Maestro System (REF100) | Moon Surgical | Jun 3, 2024 | SESE |
| K221410 | Maestro Platform | Moon Surgical | Dec 2, 2022 | SESE |
| K090136 | STERIS CMAX XLT SURGICAL TABLE | STERIS Corporation | Mar 20, 2009 | SESE |
| K972810 | OPT80 THE TRANSPORTABLE (OPT80) | O.P.T. USA, Inc. | Aug 26, 1997 | SESE |
| K971988 | ALLEN, ULTRA AND SMART SOCKETS | Allen Medical Systems, Inc. | Jul 11, 1997 | SESE |
| K971307 | AMSCO SURGICAL TABLE | STERIS Corporation | Jun 27, 1997 | SESE |
| K963506 | TENET RADIOLUCENT HAND TABLE | Tenet Medical Engineering | Jan 9, 1997 | SESE |
| K961886 | DRAGER GEMINA WALL-MOUNTED WORKPLACE | Alm Surgical Equipment, Inc. | Jul 30, 1996 | SESE |
| K961742 | DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM | Alm Surgical Equipment, Inc. | Jul 26, 1996 | SESE |
| K955750 | TELETOM | Berchtold Holding GmbH | Feb 8, 1996 | SESE |
| K953980 | KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT | Kreuzer Corp. | Nov 16, 1995 | SESE |
| K951854 | LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY | Leonard Medical, Inc. | Jun 21, 1995 | SESE |
| K950192 | SKYTRON SKYBOOM SERIES | Skytron, Div. the Kmw Group, Inc. | Apr 3, 1995 | SESE |
| K926463 | RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES | Midmark Corp. | Oct 21, 1994 | SESE |
| K942486 | IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE | Mdt Corp., Inc. | Aug 10, 1994 | SESE |
| K942043 | DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E | Alm Surgical Equipment, Inc. | Jul 13, 1994 | SESE |
| K941150 | MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES | Mdt Technology For Life | Jun 10, 1994 | SESE |
| K940068 | STRYKER OPERATING ROOM TABLE | Stryker Medical | May 5, 1994 | SESE |
| K936308 | ENDEX ENDOSCOPIC POSITIONING SYSTEM | Andronic Devices, Ltd. | Mar 31, 1994 | SESE |
| K926525 | 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
