510(k) K251037

Rectal Applicator by Nucletron B.V. — Product Code JAQ

K251037 is an FDA 510(k) premarket notification submitted by Nucletron B.V. for the device "Rectal Applicator". The FDA issued a decision of Substantially Equivalent on December 19, 2025. 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.