Mec/Surgitek Products
Country not established
- Devices
- 2
What Mec/Surgitek Products makes
Mec/Surgitek Products manufactures surgical products including the Surgitek ULTRA-LO CUFF, a low-profile cuff for medical applications, and the Surgitek NEPHROSTENT KIT, designed for nephrostomy procedures.
The company’s portfolio consists of Class II devices, authorised via the FDA’s 510(k) pathway. These products are listed under the US regulatory framework and are based in the United States.
Catalogue
Surgitek Ultra-Lo Cuff Ref K830504
Regimes: 510(k) Registry: 510(k)Surgitek Nephrostent Kit Ref K831446
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mec/Surgitek Products have in the registry?
The registry currently lists 2 devices for Mec/Surgitek Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mec/Surgitek Products's devices?
Among its 2 most recently registered devices, Mec/Surgitek Products has devices listed in FDA 510(k) (2 devices).
What risk classes do Mec/Surgitek Products's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mec/Surgitek Products's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mec/Surgitek Products in the registry?
The most recently registered devices listed for Mec/Surgitek Products include SURGITEK ULTRA-LO CUFF and SURGITEK NEPHROSTENT KIT.