Radionics, A Division of Tyco Healthcare Group LP: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Radionics, A Division of Tyco Healthcare Group LP” (first 2001, latest 2005), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 55 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Integra LifeSciences, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 2 |
| GXI | Probe, Radiofrequency Lesion | 1 | 1 |
| GZL | Electrode, Depth | 1 | 1 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 | 1 |
Review panels
- Neurology (4)
- Radiology (3)
- General and Plastic Surgery (1)
Most recent Radionics, A Division of Tyco Healthcare Group LP 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051947 | RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE | LFL | 2005-08-22 | 35 |
| K041997 | RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE | MUJ | 2004-08-27 | 32 |
| K032054 | RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE | HAW | 2003-09-15 | 75 |
| K023519 | RADIONICS VARILINK 2 | IYE | 2003-01-16 | 87 |
| K021942 | RADIONICS POLE NEEDLES | GXI | 2002-09-11 | 90 |
| K013661 | XPLAN 2.2 WITH THE BODY SYSTEM | MUJ | 2001-12-03 | 27 |
| K012850 | RECORDING AND STIMULATING ELECTRODE | GZL | 2001-11-19 | 87 |
| K010548 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | HAW | 2001-03-12 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Radionics, A Division of Tyco Healthcare Group LP.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Radionics, Inc. (56 510(k)s)
- Radionics Software Applications, Inc. (12 510(k)s)
- Radionics Medical, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Radionics, A Division of Tyco Healthcare Group LP?
FDA lists 8 510(k) clearances under the applicant name “Radionics, A Division of Tyco Healthcare Group LP” (first 2001, latest 2005), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Radionics, A Division of Tyco Healthcare Group LP?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radionics, A Division of Tyco Healthcare Group LP is 55 days.
Which FDA product codes appear under Radionics, A Division of Tyco Healthcare Group LP?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 2); MUJ (System, Planning, Radiation Therapy Treatment, 2); GXI (Probe, Radiofrequency Lesion, 1).
Next steps
- See all 8 Radionics, A Division of Tyco Healthcare Group LP clearances with predicates and recalls
- Run predicate analysis for product code HAW, Radionics, A Division of Tyco Healthcare Group LP's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.