GDCClass I
Table, Operating-Room, Electrical
21 CFR 878.4960 / General, Plastic Surgery
GDC is the FDA product code for Table, Operating-Room, Electrical, a class I device type, regulated under 21 CFR 878.4960. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 27 recalls.
Classification record
- Product code
- GDC
- Device name
- Table, Operating-Room, Electrical
- Regulation
- 21 CFR 878.4960
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 18
- Ingested recalls
- 27
Clearances, product code GDC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 2 |
| 1984 | 1 |
| 1985 | 7 |
| 1988 | 1 |
| 1991 | 2 |
| 1994 | 2 |
| 1997 | 3 |
Applicants with the most clearances
Product code GDC| Applicant | Clearances |
|---|---|
| Skytron, LLC | 4 |
| Stierlen-Maquet AG | 3 |
| Mdt Corp., Inc. | 2 |
| Allen Medical Systems, Inc. | 1 |
| American Hamilton | 1 |
| American Sterilizer Co. | 1 |
| Carl Zeiss, Inc. | 1 |
| Midmark Corp | 1 |
| Ohio Medical Instrument Co., Inc. | 1 |
| STERIS Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Ads Dental System Inc.
- Advanced Instrumentations, Inc.
- Aesculap Inc
- AKRUS GmbH & Co. KG
- Anetic Aid Ltd
- Anholt Technologies Inc.
- Apothecaries Sundries Mfg Pvt Ltd
- Apramed Industria e Comercio de Aparelhos Medicos Ltda
- Aspen Surgical Products, Inc.
- Balaji Surgical
- Baxter Medical Systems (Suzhou) Co. Ltd
- Baxter Medical Systems GmbH + Co. KG
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
