FDA product code FQP: Lamp, Operating-Room
FQP is the FDA product code for lamp, operating-room. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under FQP, from 5 different applicants. The average 510(k) review took 52 days (median 63).
Classification
| Field | Value |
|---|---|
| Device name | Lamp, Operating-Room |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Top FQP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aculux | 1 | 2000-06-23 |
| Synthes (Usa) | 1 | 1999-12-06 |
| American Sterilizer Co. | 1 | 1978-10-17 |
| Sybron Corp. | 1 | 1977-05-23 |
| Amsco Co. | 1 | 1977-01-26 |
Most recent FQP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001223 | Aculux | ACULUX, MODEL AX3001, AX3002 | 2000-06-23 | 67 |
| K993314 | Synthes (Usa) | SYNTHES LIGHT GUIDE | 1999-12-06 | 63 |
| K781581 | American Sterilizer Co. | SURGICAL LIGHT 22 SERIES | 1978-10-17 | 32 |
| K770812 | Sybron Corp. | HANDLES, LIGHT, SURGICAL, STEOILE | 1977-05-23 | 20 |
| K761018 | Amsco Co. | SURGICAL LIGHT - CHALLENGE 22 SERIES | 1977-01-26 | 77 |
Recalls for FQP devices
openFDA lists no recalls for product code FQP.
Frequently asked questions
What is FDA product code FQP?
FQP is the FDA product code for lamp, operating-room. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is FQP?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FQP?
Across 5 cleared submissions the average was 52 days from receipt to decision (median 63).
Which companies have the most FQP clearances?
Aculux (1); Synthes (Usa) (1); American Sterilizer Co. (1); Sybron Corp. (1); Amsco Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FQP
- Run a recall and safety report across every FQP manufacturer
- Watch product code FQP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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