New Leaf Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What New Leaf Medical, Inc. makes
New Leaf Medical, Inc. manufactures electrosurgical cutting and coagulation devices, including associated accessories, as well as electronic vacuum-assisted wound closure systems (e-VAC). These tools are designed for surgical procedures requiring precise tissue management and wound drainage.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
E-Vac Ref K073455
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does New Leaf Medical, Inc. have in the registry?
The registry currently lists 2 devices for New Leaf Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list New Leaf Medical, Inc.'s devices?
Among its 2 most recently registered devices, New Leaf Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do New Leaf Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for New Leaf Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from New Leaf Medical, Inc. in the registry?
The most recently registered devices listed for New Leaf Medical, Inc. include ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES and E-VAC.