OncoPatch
FDA 510(k) clearance K252296 · decided 2025-12-05
Clearance details
- K-number
- K252296
- Device name
- OncoPatch
- Applicant
- Oncopatch, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-23
- Decision date
- 2025-12-05
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- KXK
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Aurora, CO, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| GammaTile (K221539) | Gt Medical Technologies | 2022-11-09 |
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| LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (K193602) | Lv Liberty Vision Corporation | 2020-05-29 |
| GammaTile (K190839) | Gt Medical Technologies | 2020-01-23 |
| CivaDerm (K191324) | Civatech Oncology, Inc. | 2019-09-20 |
| GammaTile (K190296) | Gt Medical Technologies | 2019-03-13 |
| GammaTile (K180515) | Isoray Medical, Inc. | 2018-07-06 |
| Sirius MRI Marker NS (K171487) | C4 Imaging, LLC | 2017-08-25 |
| LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source (K163572) | Lv Liberty Vision Corp. | 2017-03-15 |
| SMD-Sr90-DA Radionuclide Brachytherapy Source (K163206) | Salutaris Medical Devices, Inc. | 2016-12-15 |
Recalls involving this device
No recalls on record reference this clearance.