GDC — Table, Operating-Room, Electrical Class I
FDA product code GDC covers "Table, Operating-Room, Electrical", a Class I medical device regulated under 21 CFR 878.4960. Submissions are reviewed by the General, Plastic Surgery panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GDC
- Device Class
- Class I
- Regulation Number
- 878.4960
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K971390 | steris corporation | QUANTUM 3080SP SURGICAL TABLE | May 15, 1997 |
| K970807 | stierlen-maquet | MOBILE OPERATING TABLE 1132.01 | March 14, 1997 |
| K964273 | allen medical systems | DURA-BOARD ARMBOARD | January 8, 1997 |
| K940616 | skytron, div. the kmw group | SKYTRON ELITE 3500 TABLE | June 13, 1994 |
| K934744 | midmark | MIDMARK MAGNUM GENERAL SURGICAL TABLE | March 28, 1994 |
| K914758 | mdt corp | MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE | December 19, 1991 |
| K915393 | mdt corp | MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE | December 17, 1991 |
| K883613 | stierlen-maquet | OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. | September 15, 1988 |
| K853720 | carl zeiss | MOBILE OPERATING TABLE FOR ORL MICROSURGERY | October 18, 1985 |
| K853480 | skytron, div. the kmw group | SKYTRON ELITE 6000 & 6001 SURGICAL TABLES | September 12, 1985 |
| K853535 | xre | TRAUMA TABLE | September 11, 1985 |
| K851021 | ohio medical instrument co | MAYFIELD TABLE-ELECTRIC | May 21, 1985 |
| K851830 | skytron, div. the kmw group | SKYTRON ELITE 7000 MICRO-SURGERY TABLE | May 17, 1985 |
| K851829 | skytron, div. the kmw group | SKYTRON ELITE 3100 SURGICAL TABLE | May 17, 1985 |
| K850168 | stille-werner (usa) | STILLE SCANDIA OPERATING TABLES RC 3000,1100 | March 28, 1985 |
| K843134 | stierlen-maquet | MOBILE OPERATING TABLE HEIDELBERGS 1130 | September 7, 1984 |
| K821749 | american sterilizer | AMSCO ENDOSCOPY TABLE | July 9, 1982 |
| K821665 | american hamilton | PEDESTAL EXAMINING TABLE | June 24, 1982 |