FDA product code FSS: Light, Surgical, Floor Standing
FSS is the FDA product code for light, surgical, floor standing. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 20 510(k) submissions under FSS, from 17 different applicants. The average 510(k) review took 62 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Light, Surgical, Floor Standing |
| 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 FSS clearance
Top FSS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cuda Products Co. | 3 | 1998-08-18 |
| Kinetic Biomedical Services, Inc. | 2 | 1989-04-19 |
| Trumpf Medizin Systeme GmbH + Co. KG | 1 | 2009-09-28 |
| Medical Illumination International, Inc. | 1 | 2001-02-02 |
| Aesculap, Inc. | 1 | 1999-02-01 |
12 more applicants have FSS clearances. See the full list in Caduvo.
Most recent FSS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091246 | Trumpf Medizin Systeme GmbH + Co. KG | ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) | 2009-09-28 | 154 |
| K003489 | Medical Illumination International, Inc. | NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 | 2001-02-02 | 81 |
| K984124 | Aesculap, Inc. | AESCULAP XENON LIGHT SOURCE | 1999-02-01 | 75 |
| K981962 | Cuda Products Co. | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | 1998-08-18 | 75 |
| K981821 | Angiolaz, Inc. | VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR | 1998-07-29 | 68 |
Recalls for FSS devices
openFDA lists no recalls for product code FSS.
Frequently asked questions
What is FDA product code FSS?
FSS is the FDA product code for light, surgical, floor standing. 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 FSS?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSS?
Across 20 cleared submissions the average was 62 days from receipt to decision (median 60).
Which companies have the most FSS clearances?
Cuda Products Co. (3); Kinetic Biomedical Services, Inc. (2); Trumpf Medizin Systeme GmbH + Co. KG (1); Medical Illumination International, Inc. (1); Aesculap, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FSS
- Run a recall and safety report across every FSS manufacturer
- Watch product code FSS 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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