510(k) K172611

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 by Varian Medical Systems, Inc. — Product Code JAQ

K172611 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "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". The FDA issued a decision of Substantially Equivalent on Mar 21, 2018. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Varian Medical Systems, Inc. has 205 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 21, 2018
Date Received
Aug 31, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type
510(k)