Data / Medical devices / Angioscope
Angioscope (LYK): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Angioscope (product code LYK, Class 2, 21 CFR 876.1500). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 41 510(k) clearances under this code, the latest on January 28, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LYK
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| Germany | 2 |
| United States | 2 |
| Canada | 1 |
Makers of Angioscope
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 |
|---|---|---|---|---|---|---|---|---|
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 2 | April 17, 2002 | 0 | 0 | 0 | api.fda.gov |
| Vena Medical Holdings Corp. | Kitchener Ontario, Canada | Complaint file establishment, Manufacturer | 2 | January 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Endovision, Inc. | Charlton, MA, United States | Contract manufacturer | 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 | |
| Myriad Fiber Imaging Technologies, Inc. | Dudley, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 28, 2026. 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.