510(k) K243939

Titanium Flexible Geometry FSD Applicator Set (GM11013400) by Varian Medical Systems, Inc. — Product Code JAQ

K243939 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Titanium Flexible Geometry FSD Applicator Set (GM11013400)". The FDA issued a decision of Substantially Equivalent on March 3, 2025. 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 at least 10 other 510(k) clearances on record.