Gynecare, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Gynecare, Inc. makes
Gynecare, Inc. manufactures electrosurgical systems and uterine balloon therapy devices. The VERSAPOINT G-VAP ELECTRODE and VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) are designed for gynecological electrosurgical procedures, including tissue ablation. The THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM is intended for endometrial ablation to treat abnormal uterine bleeding.
The company’s devices are regulated under FDA pathways, including 510(k) clearance for Class II products and PMA approval for Class III devices. These products are listed in the FDA’s regulatory records, and the manufacturer operates from the United States.
Catalogue
Gynecare Versapoint G-Vap Electrode Ref K992901
510(k) 510(k)Versapoint Electrosurgery System (Scuba) Ref K982738
510(k) 510(k)Scuba System Ref K962482
510(k) 510(k)- PMA, withdrawn PMA
Frequently asked questions
How many devices does Gynecare, Inc. have in the registry?
The registry currently lists 4 devices for Gynecare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gynecare, Inc.'s devices?
Among its 4 most recently registered devices, Gynecare, Inc. has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Gynecare, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Gynecare, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Gynecare, Inc. in the registry?
The most recently registered devices listed for Gynecare, Inc. include GYNECARE VERSAPOINT G-VAP ELECTRODE, VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA), SCUBA SYSTEM and GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM.