FWXClass I
Table, Operating-Room, Mechanical
21 CFR 878.4950 / General, Plastic Surgery
FWX is the FDA product code for Table, Operating-Room, Mechanical, a class I device type, regulated under 21 CFR 878.4950. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- FWX
- Device name
- Table, Operating-Room, Mechanical
- Regulation
- 21 CFR 878.4950
- 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
- 3
- Ingested recalls
- 1
Clearances, product code FWX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1984 | 1 |
| 1988 | 1 |
Applicants with the most clearances
Product code FWX| Applicant | Clearances |
|---|---|
| Alm Surgical Equipment, Inc. | 1 |
| Emerson-Sack-Warner Corp. | 1 |
| Surgi-Quip Inc.U | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Apothecaries Sundries Mfg Pvt Ltd
- Barrfab Industria Comercio Importacao de Equipamentos Hospit
- BenQ Medical Technology Corporation
- Black Forest Medical GmbH
- Hospital & Homecare Imp. & EXP. Co., Ltd
- Klyo Medical Systems Inc
- Medacta International SA
- Narang Medical, Ltd.
- PT. Mega Andalan Kalasan
- Shanghai Huifeng Medical Instrument Co., Ltd.
- Shanghai PAX Medical Instrument Co., Ltd.
- United Poly Engineering Pvt. Ltd.
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.
