Gynecare, A Div. of Ethicon, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Gynecare, A Div. of Ethicon, Inc. makes
Gynecare manufactures synthetic surgical mesh products, including the GYNEMESH PROLENE SOFT for pelvic floor repair, and urological tools like the VERSAPOINT resectoscopic system.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh For Pelvic Floor Repair Ref K013718
Regimes: 510(k) Registry: 510(k)Versapoint Resectoscopic System Ref K040302
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gynecare, A Div. of Ethicon, Inc. have in the registry?
The registry currently lists 2 devices for Gynecare, A Div. of Ethicon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gynecare, A Div. of Ethicon, Inc.'s devices?
Among its 2 most recently registered devices, Gynecare, A Div. of Ethicon, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Gynecare, A Div. of Ethicon, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gynecare, A Div. of Ethicon, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gynecare, A Div. of Ethicon, Inc. in the registry?
The most recently registered devices listed for Gynecare, A Div. of Ethicon, Inc. include GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR and VERSAPOINT RESECTOSCOPIC SYSTEM.