Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths
FDA 510(k) clearance K160516 · decided 2016-08-10
Clearance details
- K-number
- K160516
- Device name
- Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths
- Applicant
- Varian Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-02-24
- Decision date
- 2016-08-10
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- JAQ
- Device class
- 2
- Regulation number
- 892.5700
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.