510(k) K160610

Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set by Kobold, LLC — Product Code JAQ

K160610 is an FDA 510(k) premarket notification submitted by Kobold, LLC for the device "Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set". The FDA issued a decision of Substantially Equivalent on Feb 13, 2017. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Kobold, LLC has 2 other 510(k) clearances on record.