K160516 is an FDA 510(k) clearance for the 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. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on August 10, 2016, 168 days after receiving the submission on February 24, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K160516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2016 |
| Decision Date | August 10, 2016 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAQ — System, Applicator, Radionuclide, Remote-controlled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5700 |