510(k) K960757

KARL STORZ URETER RESECTOSCOPE by KARL STORZ Endoscopy-America, Inc. — Product Code FJL

K960757 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ URETER RESECTOSCOPE". The FDA issued a decision of Substantially Equivalent on May 1, 1996. 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.