K252296
- 510(k) number
- K252296
- Device name
- OncoPatch
- Applicant
- Oncopatch, Inc. CO · US
- Product code
- KXK — Source, Brachytherapy, Radionuclide
- Decision date
- 2025-12-05
- Date received
- 2025-07-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252296.pdf
Official FDA record: K252296
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.