Table, Operating-Room, Electrical
The Table, Operating-Room, Electrical (product code GDC) is an electrically adjustable operating table used to position patients during surgical procedures, providing the range of motion and stability required for general and plastic surgery. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4960 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GDC
- Device Class
- FDA class 1
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K971390 | QUANTUM 3080SP SURGICAL TABLE | May 15, 1997 | Substantially Equivalent | STERIS Corporation |
| K970807 | MOBILE OPERATING TABLE 1132.01 | Mar 14, 1997 | Substantially Equivalent | Stierlen-Maquet AG |
| K964273 | DURA-BOARD ARMBOARD | Jan 08, 1997 | Substantially Equivalent | Allen Medical Systems, Inc. |
| K940616 | SKYTRON ELITE 3500 TABLE | Jun 13, 1994 | Substantially Equivalent | Skytron, Div. the Kmw Group, Inc. |
| K934744 | MIDMARK MAGNUM GENERAL SURGICAL TABLE | Mar 28, 1994 | Substantially Equivalent | Midmark Corp. |
| K914758 | MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE | Dec 19, 1991 | Substantially Equivalent | Mdt Corp., Inc. |
| K915393 | MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE | Dec 17, 1991 | Substantially Equivalent | Mdt Corp., Inc. |
| K883613 | OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. | Sep 15, 1988 | Substantially Equivalent | Stierlen-Maquet AG |
| K853720 | MOBILE OPERATING TABLE FOR ORL MICROSURGERY | Oct 18, 1985 | Substantially Equivalent | Carl Zeiss, Inc. |
| K853480 | SKYTRON ELITE 6000 & 6001 SURGICAL TABLES | Sep 12, 1985 | Substantially Equivalent | Skytron, Div. the Kmw Group, Inc. |
| K853535 | TRAUMA TABLE | Sep 11, 1985 | Substantially Equivalent | Xre Corp. |
| K851021 | MAYFIELD TABLE-ELECTRIC | May 21, 1985 | Substantially Equivalent | Ohio Medical Instrument Co., Inc. |
| K851830 | SKYTRON ELITE 7000 MICRO-SURGERY TABLE | May 17, 1985 | Substantially Equivalent | Skytron, Div. the Kmw Group, Inc. |
| K851829 | SKYTRON ELITE 3100 SURGICAL TABLE | May 17, 1985 | Substantially Equivalent | Skytron, Div. the Kmw Group, Inc. |
| K850168 | STILLE SCANDIA OPERATING TABLES RC 3000,1100 | Mar 28, 1985 | Substantially Equivalent | Stille-Werner (Usa), Inc. |
| K843134 | MOBILE OPERATING TABLE HEIDELBERGS 1130 | Sep 07, 1984 | Substantially Equivalent | Stierlen-Maquet AG |
| K821749 | AMSCO ENDOSCOPY TABLE | Jul 09, 1982 | Substantially Equivalent | American Sterilizer Co. |
| K821665 | PEDESTAL EXAMINING TABLE | Jun 24, 1982 | Substantially Equivalent | American Hamilton |
FEI Numbers
This FDA classification entry is associated with 111 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 111 registration numbers. Click on an entry to view related FDA registrations.