510(k) K161688

Advanced Gynecological Applicator by Nucletron B.V. — Product Code JAQ

K161688 is an FDA 510(k) premarket notification submitted by Nucletron B.V. for the device "Advanced Gynecological Applicator". The FDA issued a decision of Substantially Equivalent on January 27, 2017. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron B.V. has at least 10 other 510(k) clearances on record.