Radionics, A Division of Tyco Healthcare Group LP
United StatesFDA applicant, unverified
- Devices
- 8
What Radionics, A Division of Tyco Healthcare Group LP makes
The company manufactures surgical and diagnostic devices, including the XKnife RT 3 with a non-stereotactic module for tissue ablation, the CUSA Excel ultrasonic surgical aspirator system with bone attachment for tissue removal, and the Nashold biopsy needle for single-use tissue sampling. Additional products include the Varilink 2 for surgical connections, recording and stimulating electrodes for neurological applications, and modifications to optical tracking systems for precision guidance. Pole needles and the XPlan 2.2 with the Body System for surgical planning are also part of the portfolio.
These devices are classified under FDA categories Class II and Unclassified (U), with regulatory submissions recorded via the 510(k) pathway. The company is based in the United States, and its products are listed in the FDA’s 510(k) registry.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Radionics Varilink 2 Ref K023519
Regimes: 510(k) Registry: 510(k)Modification To Optical Tracking System (Ots) Ref K010548
Regimes: 510(k) Registry: 510(k)Radionics Nashold Biopsy Needle - Single Use Ref K032054
Regimes: 510(k) Registry: 510(k)Recording And Stimulating Electrode Ref K012850
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Radionics Pole Needles Ref K021942
Regimes: 510(k) Registry: 510(k)Xplan 2.2 With The Body System Ref K013661
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Radionics, A Division of Tyco Healthcare Group LP have in the registry?
The registry currently lists 8 devices for Radionics, A Division of Tyco Healthcare Group LP. Devices recorded under merged duplicate company entries are counted once.
Which registries list Radionics, A Division of Tyco Healthcare Group LP's devices?
Among its 8 most recently registered devices, Radionics, A Division of Tyco Healthcare Group LP has devices listed in FDA 510(k) (8 devices).
What risk classes do Radionics, A Division of Tyco Healthcare Group LP's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Radionics, A Division of Tyco Healthcare Group LP's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Radionics, A Division of Tyco Healthcare Group LP in the registry?
The most recently registered devices listed for Radionics, A Division of Tyco Healthcare Group LP include RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE, RADIONICS VARILINK 2, MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) and RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE.