510(k) K232370

Percutaneous Nephroscope System by Karl Storz SE & CO. KG — Product Code FGA

K232370 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "Percutaneous Nephroscope System". The FDA issued a decision of Substantially Equivalent on May 1, 2024. The device falls under product code FGA (Kit, Nephroscope), a Class II device regulated under 21 CFR 876.1500. Karl Storz SE & CO. KG has at least 10 other 510(k) clearances on record.