510(k) K253888

MOLLI 2 System by Stryker Endoscopy — Product Code NEU

K253888 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "MOLLI 2 System". The FDA issued a decision of Substantially Equivalent on December 31, 2025. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Stryker Endoscopy has at least 10 other 510(k) clearances on record.