Cybersonics Inc
United StatesFDA applicant, unverified
- Devices
- 31
What Cybersonics Inc makes
CyberSonics Inc manufactures ultrasonic and pneumatic lithotripsy systems for breaking kidney and urinary stones, including handpieces, transducer probes, foot switches, and power cords. Their products also include reusable surgical torque wrenches and sterile pads for system maintenance. The portfolio covers both standalone lithotripsy systems and modular components designed for use in urological procedures.
The company’s devices are classified as Class II under FDA regulations and are authorised via 510(k) premarket notifications and the FDA’s Unique Device Identification (UDI) system. These products are listed in the US and comply with applicable regulatory requirements for surgical and diagnostic equipment.
Catalogue
Search and filter all 31 devicesCompany details
- DUNS number
- 943561522
Frequently asked questions
How many devices does CYBERSONICS INC have in the registry?
The registry currently lists 31 devices for CYBERSONICS INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list CYBERSONICS INC's devices?
Among its 31 most recently registered devices, CYBERSONICS INC has devices listed in FDA 510(k) (7 devices) and FDA GUDID (24 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CYBERSONICS INC's devices fall under?
Among its 31 most recently registered devices, the classes recorded for CYBERSONICS INC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from CYBERSONICS INC in the registry?
The most recently registered devices listed for CYBERSONICS INC include CyberWand USL NoseCone Kit CW-USLNC, CyberWand Probe Set CW-RBP, Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 5.5 Fr (1.83mm) X 418mm SPL-PD183 and Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 4.5Fr (1.50mm) X 564mm SPL-PD150.