Primaeva Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Primaeva Medical, Inc. makes
Primaeva Medical, Inc. manufactures the Finesse System, the Renesis System, and the Primaeva Medical System, which are designed for minimally invasive surgical procedures, including gynecological interventions.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Finesse System Ref K072261
Regimes: 510(k) Registry: 510(k)Primaeva Medical Renesis System Ref K082391
Regimes: 510(k) Registry: 510(k)Primaeva Medical System Ref K080145
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Primaeva Medical, Inc. have in the registry?
The registry currently lists 3 devices for Primaeva Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Primaeva Medical, Inc.'s devices?
Among its 3 most recently registered devices, Primaeva Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Primaeva Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Primaeva Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Primaeva Medical, Inc. in the registry?
The most recently registered devices listed for Primaeva Medical, Inc. include FINESSE SYSTEM, PRIMAEVA MEDICAL RENESIS SYSTEM and PRIMAEVA MEDICAL SYSTEM.