K240495
- 510(k) number
- K240495
- Device name
- Flexible Fixation Device for Gynecological Applicators (GM11001960)
- Applicant
- Varian Medical Systems, Inc. CA · US
- Product code
- JAQ — System, Applicator, Radionuclide, Remote-Controlled
- Decision date
- 2024-05-09
- Date received
- 2024-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240495.pdf
Official FDA record: K240495
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.