FQPClass II
Lamp, Operating-Room
21 CFR 878.4580 / General, Plastic Surgery
FQP is the FDA product code for Lamp, Operating-Room, a class II device type, regulated under 21 CFR 878.4580. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FQP
- Device name
- Lamp, Operating-Room
- 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
- 5
- Ingested recalls
- 0
Clearances, product code FQP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 1 |
| 1999 | 1 |
| 2000 | 1 |
Applicants with the most clearances
Product code FQP| Applicant | Clearances |
|---|---|
| Aculux | 1 |
| American Sterilizer Co. | 1 |
| Amsco Co. | 1 |
| Sybron Corp. | 1 |
| Synthes (USA) Products LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Ads Dental System Inc.
- Baxter Medical Systems GmbH + Co. KG
- Better Medical Technology Co., Ltd.
- Caf Medical Solutions Inc
- Depuy Orthopaedics Inc.
- Eclipse Prism Medical Devices Pvt. Ltd
- Exel Inc. dba DHL Supply Chain (USA)
- Gamamed Vascular Systems Inc.
- Guangzhou Ajax Medical Equipment Co Ltd
- Harbin Howell Medical Apparatus and Instruments Co.,Ltd.
- Hebei Webian Medical Instrument Trading Co., Ltd
- Hefei Mt Medical Co.,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.
