510(k) K221893

KARL STORZ Bipolar Resectoscopes with HF Cable by Karl Storz Endoscopy America, Inc. — Product Code FJL

K221893 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy America, Inc. for the device "KARL STORZ Bipolar Resectoscopes with HF Cable". The FDA issued a decision of Substantially Equivalent on March 17, 2023. The device falls under product code FJL (Resectoscope), a Class II device regulated under 21 CFR 876.1500. Karl Storz Endoscopy America, Inc. has at least 10 other 510(k) clearances on record.