510(k) K945907

KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES by KARL STORZ Endoscopy-America, Inc. — Product Code FGC

K945907 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES". The FDA issued a decision of Substantially Equivalent on May 12, 1995. The device falls under product code FGC (Urethroscope), 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.