510(k) Report

FDA applicant

Radionics, A Division of Tyco Healthcare Group LP

Burlington, MA8 decisions2001–20050 recalls

FDA records 8 decisions for Radionics, A Division of Tyco Healthcare Group LP (Burlington, MA) from 2001 to 2005: 8 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 16 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Radionics, A Division of Tyco Healthcare Group LP’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Radionics, A Division of Tyco Healthcare Group LP since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Radionics, A Division of Tyco Healthcare Group LP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Radionics, A Division of Tyco…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument2decisions
  • MUJSystem, Planning, Radiation Therapy Treatment2decisions
  • GZLElectrode, Depth1decision
  • IYEAccelerator, Linear, Medical1decision
  • LFLInstrument, Ultrasonic Surgical1decision
  • GXIProbe, Radiofrequency Lesion1decision

Whose devices does it build on?

Its devices cite 16 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051947Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 20055cite it
  • K021942Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 20023cite it
  • K012850Recording and Stimulating ElectrodeRadionics, A Division of Tyco Healthcare Group LP · 20011cites it
  • K032054Radionics Nashold Biopsy Needle - Single UseRadionics, A Division of Tyco Healthcare Group LP · 20031cites it
  • K041997Radionics Xknife RT 3 with Non Stereotactic ModuleRadionics, A Division of Tyco Healthcare Group LP · 20041cites it
  • K013661Xplan 2.2 with the Body SystemRadionics, A Division of Tyco Healthcare Group LP · 20011cites it

What has FDA decided for it lately?

  • K051947Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005
  • K041997Radionics Xknife RT 3 with Non Stereotactic ModuleRadionics, A Division of Tyco Healthcare Group LP · 2004
  • K032054Radionics Nashold Biopsy Needle - Single UseRadionics, A Division of Tyco Healthcare Group LP · 2003
  • K023519Radionics Varilink 2Radionics, A Division of Tyco Healthcare Group LP · 2003
  • K021942Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 2002
  • K013661Xplan 2.2 with the Body SystemRadionics, A Division of Tyco Healthcare Group LP · 2001
  • K012850Recording and Stimulating ElectrodeRadionics, A Division of Tyco Healthcare Group LP · 2001
  • K010548Modification to Optical Tracking System (Ots)Radionics, A Division of Tyco Healthcare Group LP · 2001

All 8 as Radionics, A Division of Tyco Healthcare Group LP →

Other applicant names beginning “Radionics”

FDA records each applicant name separately; these may or may not be the same firm.

Radionics, Inc. 56Radionics Software Applications, Inc. 12Radionics Medical, Inc. 5