FDA product code FST: Light, Surgical, Fiberoptic
FST is the FDA product code for light, surgical, fiberoptic. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 45 510(k) submissions under FST, from 35 different applicants. The average 510(k) review took 79 days (median 70). FDA has posted 12 recalls for FST devices.
Classification
| Field | Value |
|---|---|
| Device name | Light, Surgical, Fiberoptic |
| 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) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FST
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 90 |
Top FST applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Surgical Products, Inc. | 5 | 1988-03-14 |
| Cuda Products Co. | 3 | 1990-06-18 |
| Invuity, Inc. | 2 | 2012-02-10 |
| Sensormed | 2 | 2012-01-12 |
| Medical Illumination International, Inc. | 2 | 2010-06-22 |
30 more applicants have FST clearances. See the full list in Caduvo.
Most recent FST clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200874 | Innovasis, Inc. | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | 2020-06-30 | 90 |
| K141330 | Enroxtech, Inc. | ENDO-CORD | 2014-12-15 | 208 |
| K122637 | Stryker Spine | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 | 2012-11-01 | 64 |
| K113697 | Invuity, Inc. | EIGR SURGICAL ILLUMINATION SYSTEM | 2012-02-10 | 56 |
| K113330 | Sensormed | CABLECAP | 2012-01-12 | 59 |
Recalls for FST devices
12 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-11-26.
Frequently asked questions
What is FDA product code FST?
FST is the FDA product code for light, surgical, fiberoptic. 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 FST?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k).
How long does a 510(k) take for product code FST?
Across 45 cleared submissions the average was 79 days from receipt to decision (median 70).
Which companies have the most FST clearances?
Advanced Surgical Products, Inc. (5); Cuda Products Co. (3); Invuity, Inc. (2); Sensormed (2); Medical Illumination International, Inc. (2).
Have FST devices been recalled?
Yes: 12 product recalls across 4 recall events; the most recent began 2014-11-26.
Next steps
- Run an FDA pathway report with predicate devices for product code FST
- Run a recall and safety report across every FST manufacturer
- Watch product code FST 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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