510(k) K241965

Catheter Surface Flap Applicator Set (GM11011830) by Varian Medical Systems — Product Code JAQ

K241965 is an FDA 510(k) premarket notification submitted by Varian Medical Systems for the device "Catheter Surface Flap Applicator Set (GM11011830)". The FDA issued a decision of Substantially Equivalent on October 29, 2024. 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 has at least 10 other 510(k) clearances on record.