FDA product code FCS: Light, Catheter, Fiberoptic, Glass, Ureteral
FCS is the FDA product code for light, catheter, fiberoptic, glass, ureteral. It is a Class II device, regulated under 21 CFR 876.4020 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 10 510(k) submissions under FCS, from 8 different applicants. The average 510(k) review took 152 days (median 117). FDA has posted 3 recalls for FCS devices.
Classification
| Field | Value |
|---|---|
| Device name | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Device class | Class II |
| Regulation | 21 CFR 876.4020 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FCS clearance
Top FCS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stryker Endoscopy | 2 | 2015-08-20 |
| Gabriel Medical, Inc. | 2 | 1995-02-07 |
| Stryker Corp. | 1 | 2006-09-28 |
| Rocket of London, Ltd. | 1 | 1995-08-15 |
| Apple Medical Corp. | 1 | 1994-10-05 |
3 more applicants have FCS clearances. See the full list in Caduvo.
Most recent FCS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151243 | Stryker Endoscopy | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] | 2015-08-20 | 101 |
| K061548 | Stryker Corp. | STRYKER URETERAL ILLUMINATION SYSTEM IV | 2006-09-28 | 115 |
| K982542 | Stryker Endoscopy | STRYKER URETERAL ILLUMINATOR SYSTEM III | 1998-09-22 | 63 |
| K943801 | Rocket of London, Ltd. | URIGLOW TRANSILLUMINATING URETERIC STENT MODEL | 1995-08-15 | 377 |
| K945088 | Gabriel Medical, Inc. | GABRIEL URETERAL ILLUMINATOR SYSTEM II | 1995-02-07 | 113 |
Recalls for FCS devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-03-07.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code FCS?
FCS is the FDA product code for light, catheter, fiberoptic, glass, ureteral. It is a Class II device, regulated under 21 CFR 876.4020 and reviewed by the Gastroenterology and Urology panel.
What device class is FCS?
Class II, regulation 21 CFR 876.4020. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCS?
Across 10 cleared submissions the average was 152 days from receipt to decision (median 117).
Which companies have the most FCS clearances?
Stryker Endoscopy (2); Gabriel Medical, Inc. (2); Stryker Corp. (1); Rocket of London, Ltd. (1); Apple Medical Corp. (1).
Have FCS devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2017-03-07.
Next steps
- Run an FDA pathway report with predicate devices for product code FCS
- Run a recall and safety report across every FCS manufacturer
- Watch product code FCS 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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