Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths
FDA 510(k) clearance K172611 · decided 2018-03-21
Clearance details
- K-number
- K172611
- Device name
- Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths
- Applicant
- Varian Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-31
- Decision date
- 2018-03-21
- Days to decision
- 202 days
- Clearance type
- Special
- 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.