# Radionics, A Division of Tyco Healthcare Group LP

- Location (FDA's records): Burlington, MA
- FDA decisions: 8 (2001–2005): 8 510(k) clearances
- Product codes: HAW (2), MUJ (2), GZL (1), IYE (1), LFL (1), GXI (1)
- Predicates its devices cite: 16 (1 its own); citations of its devices by later devices: 12 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Radionics, Inc.: 7 (https://510kreport.com/company/radionics)
- Microrecording Systems Consultants, LLC: 1 (https://510kreport.com/company/microrecording-systems-consultants)
- Valleylab, Inc.: 1 (https://510kreport.com/company/valleylab)
- Cavitron Corp.: 1 (https://510kreport.com/company/cavitron)
- Synergetics, Inc.: 1 (https://510kreport.com/company/synergetics)
- Daum Corp.: 1 (https://510kreport.com/company/daum)
- Ad-Tech Medical Instrument Corp: 1 (https://510kreport.com/company/ad-tech-medical-instrument)
- Adac Laboratories: 1 (https://510kreport.com/company/adac-laboratories)

## Firms that cite its devices most
- Integra Radionics, Inc.: 3 (https://510kreport.com/company/integra-radionics)
- PAJUNK GmbH Medizintechnologie: 2 (https://510kreport.com/company/pajunk-medizintechnologie)
- Integra LifeSciences Corporation: 2 (https://510kreport.com/company/integra-lifesciences)
- Technomed Europe: 1 (https://510kreport.com/company/technomed-europe)
- Physician Industries, Inc.: 1 (https://510kreport.com/company/physician-industries)
- Dixi Medical: 1 (https://510kreport.com/company/dixi-medical)
- Misonix, Inc.: 1 (https://510kreport.com/company/misonix)

## Its most-cited devices
- K051947: Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone (2005), cited by 5
- K021942: Radionics Pole Needles (2002), cited by 3
- K012850: Recording and Stimulating Electrode (2001), cited by 1
- K032054: Radionics Nashold Biopsy Needle - Single Use (2003), cited by 1
- K041997: Radionics Xknife RT 3 with Non Stereotactic Module (2004), cited by 1
- K013661: Xplan 2.2 with the Body System (2001), cited by 1

## Recent decisions
- K051947: Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone (Aug 22, 2005)
- K041997: Radionics Xknife RT 3 with Non Stereotactic Module (Aug 27, 2004)
- K032054: Radionics Nashold Biopsy Needle - Single Use (Sep 15, 2003)
- K023519: Radionics Varilink 2 (Jan 16, 2003)
- K021942: Radionics Pole Needles (Sep 11, 2002)
- K013661: Xplan 2.2 with the Body System (Dec 3, 2001)
- K012850: Recording and Stimulating Electrode (Nov 19, 2001)
- K010548: Modification to Optical Tracking System (Ots) (Mar 12, 2001)

Source page: https://510kreport.com/company/radionics-a-division-of-tyco-healthcare-group