GDC · Table, Operating-Room, Electrical
General, Plastic Surgery · 21 CFR 878.4960 · Class 1
Overview
| Product Code | GDC |
|---|---|
| Device Name | Table, Operating-Room, Electrical |
| 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 (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971390 | QUANTUM 3080SP SURGICAL TABLE | STERIS Corporation | May 15, 1997 | SESE |
| K970807 | MOBILE OPERATING TABLE 1132.01 | Stierlen-Maquet AG | Mar 14, 1997 | SESE |
| K964273 | DURA-BOARD ARMBOARD | Allen Medical Systems, Inc. | Jan 8, 1997 | SESE |
| K940616 | SKYTRON ELITE 3500 TABLE | Skytron, Div. the Kmw Group, Inc. | Jun 13, 1994 | SESE |
| K934744 | MIDMARK MAGNUM GENERAL SURGICAL TABLE | Midmark Corp. | Mar 28, 1994 | SESE |
| K914758 | MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE | Mdt Corp., Inc. | Dec 19, 1991 | SESE |
| K915393 | MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE | Mdt Corp., Inc. | Dec 17, 1991 | SESE |
| K883613 | OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. | Stierlen-Maquet AG | Sep 15, 1988 | SESE |
| K853720 | MOBILE OPERATING TABLE FOR ORL MICROSURGERY | Carl Zeiss, Inc. | Oct 18, 1985 | SESE |
| K853480 | SKYTRON ELITE 6000 & 6001 SURGICAL TABLES | Skytron, Div. the Kmw Group, Inc. | Sep 12, 1985 | SESE |
| K853535 | TRAUMA TABLE | Xre Corp. | Sep 11, 1985 | SESE |
| K851021 | MAYFIELD TABLE-ELECTRIC | Ohio Medical Instrument Co., Inc. | May 21, 1985 | SESE |
| K851830 | SKYTRON ELITE 7000 MICRO-SURGERY TABLE | Skytron, Div. the Kmw Group, Inc. | May 17, 1985 | SESE |
| K851829 | SKYTRON ELITE 3100 SURGICAL TABLE | Skytron, Div. the Kmw Group, Inc. | May 17, 1985 | SESE |
| K850168 | STILLE SCANDIA OPERATING TABLES RC 3000,1100 | Stille-Werner (Usa), Inc. | Mar 28, 1985 | SESE |
| K843134 | MOBILE OPERATING TABLE HEIDELBERGS 1130 | Stierlen-Maquet AG | Sep 7, 1984 | SESE |
| K821749 | AMSCO ENDOSCOPY TABLE | American Sterilizer Co. | Jul 9, 1982 | SESE |
| K821665 | PEDESTAL EXAMINING TABLE | American Hamilton | Jun 24, 1982 | SESE |
Top Applicants
- Skytron, Div. the Kmw Group, Inc. — 4 clearances
- Stierlen-Maquet AG — 3 clearances
- Mdt Corp., Inc. — 2 clearances
- Xre Corp. — 1 clearance
- Stille-Werner (Usa), Inc. — 1 clearance
