Stryker Ent
Country not established
- Devices
- 3
What Stryker Ent makes
Stryker Ent manufactures guidewire systems, including the TGS Guidewire and associated Scopis Software for procedural imaging, as well as the TGS Universal Headrest with Mounting Arm for patient positioning. The company also produces the SINUSPRIME Dilation System, designed for sinus dilation procedures.
These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The company is based in the United States.
Catalogue
TGS Guidewire and updated Scopis Software Ref K193118
Regimes: 510(k) Registry: 510(k)TGS Universal Headrest with Mounting Arm Ref K193502
Regimes: 510(k) Registry: 510(k)SINUSPRIME Dilation System Ref K201398
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stryker Ent have in the registry?
The registry currently lists 3 devices for Stryker Ent. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stryker Ent's devices?
Among its 3 most recently registered devices, Stryker Ent has devices listed in FDA 510(k) (3 devices).
What risk classes do Stryker Ent's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Stryker Ent's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stryker Ent in the registry?
The most recently registered devices listed for Stryker Ent include TGS Guidewire and updated Scopis Software, TGS Universal Headrest with Mounting Arm and SINUSPRIME Dilation System.