Accutome Ultrasound, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Accutome Ultrasound, Inc. makes
Accutome Ultrasound, Inc. manufactures ultrasound-based surgical instruments, including the ACCUPEN and ACCUPACH V, designed for precision tissue dissection and cutting in medical procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
B-Scan Plus Ref K070943
Regimes: 510(k) Registry: 510(k)Accupen Ref K083377
Regimes: 510(k) Registry: 510(k)Accupach V Ref K042752
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Accutome Ultrasound, Inc. have in the registry?
The registry currently lists 3 devices for Accutome Ultrasound, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accutome Ultrasound, Inc.'s devices?
Among its 3 most recently registered devices, Accutome Ultrasound, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Accutome Ultrasound, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Accutome Ultrasound, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Accutome Ultrasound, Inc. in the registry?
The most recently registered devices listed for Accutome Ultrasound, Inc. include B-SCAN PLUS, ACCUPEN and ACCUPACH V.