510(k) K232623

Universal Endometrial Applicator Set (GM11009840) by Varian Medical Systems, Inc. — Product Code JAQ

K232623 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Universal Endometrial Applicator Set (GM11009840)". The FDA issued a decision of Substantially Equivalent on April 9, 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, Inc. has at least 10 other 510(k) clearances on record.