510(k) K950433

KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES by KARL STORZ Endoscopy-America, Inc. — Product Code FGA

K950433 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES". The FDA issued a decision of Substantially Equivalent on March 15, 1995. The device falls under product code FGA (Kit, Nephroscope), 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.