FDA product code FSQ: Light, Surgical, Instrument
FSQ is the FDA product code for light, surgical, instrument. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under FSQ, from 4 different applicants. The average 510(k) review took 111 days (median 87).
Classification
| Field | Value |
|---|---|
| Device name | Light, Surgical, Instrument |
| 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 |
Compare with all 510(k) review times · Search every FSQ clearance
Top FSQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Products Development, Inc. | 3 | 1981-02-26 |
| Alm Surgical Equipment, Inc. | 2 | 1993-01-12 |
| Aaron Medical Industries | 1 | 1993-07-30 |
| Midmark Corp. | 1 | 1993-07-30 |
Most recent FSQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932139 | Aaron Medical Industries | LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT | 1993-07-30 | 87 |
| K930686 | Midmark Corp. | MIDMARK SURGICAL LIGHTING SYSTEMS | 1993-07-30 | 170 |
| K922409 | Alm Surgical Equipment, Inc. | ALM ILLUMINATOR SERIES LIGHT SYSTEM | 1993-01-12 | 236 |
| K921848 | Alm Surgical Equipment, Inc. | BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT | 1992-10-01 | 167 |
| K803067 | Medical Products Development, Inc. | SURG-FLEX 10 LIGHT | 1981-02-26 | 84 |
Recalls for FSQ devices
openFDA lists no recalls for product code FSQ.
Frequently asked questions
What is FDA product code FSQ?
FSQ is the FDA product code for light, surgical, instrument. 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 FSQ?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSQ?
Across 7 cleared submissions the average was 111 days from receipt to decision (median 87).
Which companies have the most FSQ clearances?
Medical Products Development, Inc. (3); Alm Surgical Equipment, Inc. (2); Aaron Medical Industries (1); Midmark Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FSQ
- Run a recall and safety report across every FSQ manufacturer
- Watch product code FSQ 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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