Data / Medical devices / Light, Catheter, Fiberoptic, Glass, Ureteral
Light, Catheter, Fiberoptic, Glass, Ureteral (FCS): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Light, Catheter, Fiberoptic, Glass, Ureteral (product code FCS, Class 2, 21 CFR 876.4020). 1 of them has a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on August 20, 2015, and lists 2 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- FCS
- Device class
- 2
- Regulation
- 876.4020
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 3 |
| Singapore | 1 |
| Ireland | 1 |
Makers of Light, Catheter, Fiberoptic, Glass, Ureteral
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 3 | August 20, 2015 | 0 | 1 | 0 | api.fda.gov |
| Carestream Health, Inc. | Rochester, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Fong's Engineering & Manufacturing Private Limited | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freudenberg Medical Ireland Limited | Leitrim, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 20, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.