510(k) K230780

MFG-05 by Zimmer Medizinsysteme GmbH — Product Code KPI

K230780 is an FDA 510(k) premarket notification submitted by Zimmer Medizinsysteme GmbH for the device "MFG-05". The FDA issued a decision of Substantially Equivalent on October 5, 2023. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Zimmer Medizinsysteme GmbH has at least 10 other 510(k) clearances on record.