Surgitek
Country not established
- Devices
- 29
What Surgitek makes
Surgitek manufactures ureteral stents, including the QUADRA-COIL and SUPER DOUBLE J designs, as well as stent kits and infusion systems for urinary applications. Their portfolio includes penile implants, external erection devices, and infection-resistant silicone components for urological procedures. They also produce urodynamic measurement systems, irrigation delivery tools, and bronchoscopy tubes with specialized cuffs. Graduated uretroscopes and lumen catheters for diagnostic and therapeutic use are part of their offerings.
The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with most submissions supported by 510(k) clearances. Products are listed in the FDA’s 510(k) registry. Surgitek operates from the United States.
Catalogue
Search and filter all 29 devicesFrequently asked questions
How many devices does Surgitek have in the registry?
The registry currently lists 29 devices for Surgitek. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgitek's devices?
Among its 29 most recently registered devices, Surgitek has devices listed in FDA 510(k) (29 devices).
What risk classes do Surgitek's devices fall under?
Among its 29 most recently registered devices, the classes recorded for Surgitek's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgitek in the registry?
The most recently registered devices listed for Surgitek include HYDROPHILIC COATED GUIDEWIRE, GRASPING FORCEPS, TISSUE EXPANDER and URETERAL CATHETER.