FSQClass II
Light, Surgical, Instrument
21 CFR 878.4580 / General, Plastic Surgery
FSQ is the FDA product code for Light, Surgical, Instrument, a class II device type, regulated under 21 CFR 878.4580. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FSQ
- Device name
- Light, Surgical, Instrument
- Regulation
- 21 CFR 878.4580
- Device class
- Class II
- 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
- 7
- Ingested recalls
- 0
Clearances, product code FSQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 3 |
| 1992 | 1 |
| 1993 | 3 |
Applicants with the most clearances
Product code FSQ| Applicant | Clearances |
|---|---|
| Medical Products Development, Inc. | 3 |
| Alm Surgical Equipment, Inc. | 2 |
| Apyx Medical Corporation | 1 |
| Midmark Corp | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Alira Medical Devices LLC
- Apothecaries Sundries Mfg Pvt Ltd
- ARCH Medical Solutions - Seabrook
- Baxter Medical Systems GmbH + Co. KG
- Depuy Orthopaedics Inc.
- DePuy Spine, Inc.
- Dongguan Kaiser Technology Co., Ltd
- Etkin Tibbi Cihazlar San. ve Tic. A.S.
- Exel Inc. dba DHL Supply Chain (USA)
- Gyrus ACMI, Inc.
- Hill-Rom Inc.
- International Sterilization Laboratory, LLC
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.
