Gynecare Center
Country not established
- Devices
- 1
What Gynecare Center makes
Gynecare Center manufactures the Tension-Free Vaginal Tape (TVT) System, a surgical mesh device used for treating stress urinary incontinence in women. The product is designed for minimally invasive placement to support the urethra and restore urinary control.
The TVT System is classified as a Class II medical device in the US and is subject to 510(k) clearance through the FDA. The company is based in the United States.
Catalogue
Gynecare Tension-Free Vaginal Tape System Ref K012628
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gynecare Center have in the registry?
The registry currently lists 1 device for Gynecare Center. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gynecare Center's devices?
Among its 1 most recently registered device, Gynecare Center has devices listed in FDA 510(k) (1 device).
What risk classes do Gynecare Center's devices fall under?
Among its 1 most recently registered device, the classes recorded for Gynecare Center's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gynecare Center in the registry?
The most recently registered devices listed for Gynecare Center include GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM.