FQOClass I
Table, Operating-Room, Ac-Powered
21 CFR 878.4960 / General, Plastic Surgery
FQO is the FDA product code for Table, Operating-Room, Ac-Powered, a class I device type, regulated under 21 CFR 878.4960. As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and 73 recalls.
Classification record
- Product code
- FQO
- Device name
- Table, Operating-Room, Ac-Powered
- 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
- 35
- Ingested recalls
- 73
Clearances, product code FQO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 1 |
| 1986 | 2 |
| 1988 | 2 |
| 1992 | 6 |
| 1993 | 4 |
| 1994 | 6 |
| 1995 | 3 |
| 1996 | 3 |
| 1997 | 4 |
| 2009 | 1 |
| 2022 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code FQO| Applicant | Clearances |
|---|---|
| Alm Surgical Equipment, Inc. | 4 |
| American Sterilizer Co. | 2 |
| Andronic Devices, Ltd. | 2 |
| Berchtold Holding GmbH | 2 |
| Koken Mfg Company, Inc. | 2 |
| Midmark Corp | 2 |
| Moon Surgical, Inc. | 2 |
| Rhino Mfg. | 2 |
| STERIS Corporation | 2 |
| Stierlen-Maquet AG | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Aesculap Inc
- AKRUS GmbH & Co. KG
- Alphatec Spine, Inc.
- Amico Clinical Solutions
- Amtai Medical Equipment, Inc.
- AMTRION GmbH (formerly Haseke & Kroemker)
- Askion GmbH
- Barrfab Industria Comercio Importacao de Equipamentos Hospit
- Bicakcilar Tibbi Cihazlar Sanayi ve Ticaret A.S.
- Composite Manufacturing, Inc.
- Datascope Corp.
- Dentis Medical Division
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.
