510(k) K242759

Geister K-Rex rongeurs by Geister Medizin Technik GmbH — Product Code HAE

K242759 is an FDA 510(k) premarket notification submitted by Geister Medizin Technik GmbH for the device "Geister K-Rex rongeurs". The FDA issued a decision of Substantially Equivalent on June 6, 2025. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Geister Medizin Technik GmbH has at least 5 other 510(k) clearances on record.