FDA product code FCW: Light Source, Fiberoptic, Routine
FCW is the FDA product code for light source, fiberoptic, routine. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 31 510(k) submissions under FCW, from 27 different applicants. The average 510(k) review took 80 days (median 59). FDA has posted 5 recalls for FCW devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Light Source, Fiberoptic, Routine |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FCW clearance
Top FCW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 2 | 2013-01-25 |
| Welch Allyn, Inc. | 2 | 1995-05-17 |
| Luxtec Corp. | 2 | 1989-04-26 |
| Pilling Co. | 2 | 1977-09-30 |
| Novaprobe Incorporated | 1 | 2014-07-24 |
22 more applicants have FCW clearances. See the full list in Caduvo.
Most recent FCW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131226 | Novaprobe Incorporated | NOVAPROBE LED LIGHT SOURCE | 2014-07-24 | 450 |
| K123956 | KARL STORZ Endoscopy-America, Inc. | POWER LED 175 | 2013-01-25 | 35 |
| K123359 | Olive Medical Corp. | OVS1 VIDEO SYSTEM | 2012-12-19 | 49 |
| K121724 | Richard Wolf Medical Instruments Corp. | ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 | 2012-09-20 | 100 |
| K093792 | Sunoptic Technologies, LLC | LED LIGHT SOURCE | 2010-03-18 | 98 |
Recalls for FCW devices
5 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-03-02.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code FCW?
FCW is the FDA product code for light source, fiberoptic, routine. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FCW?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCW?
Across 31 cleared submissions the average was 80 days from receipt to decision (median 59).
Which companies have the most FCW clearances?
KARL STORZ Endoscopy-America, Inc. (2); Welch Allyn, Inc. (2); Luxtec Corp. (2); Pilling Co. (2); Novaprobe Incorporated (1).
Have FCW devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2023-03-02.
Next steps
- Run an FDA pathway report with predicate devices for product code FCW
- Run a recall and safety report across every FCW manufacturer
- Watch product code FCW 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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