510(k) K954050

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

K954050 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "RESECTOSCOPES". The FDA issued a decision of Substantially Equivalent on November 22, 1995. 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.