510(k) K962393

KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION by KARL STORZ Endoscopy-America, Inc. — Product Code GCM

K962393 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION". The FDA issued a decision of Substantially Equivalent on September 17, 1996. The device falls under product code GCM (Endoscope, Rigid), 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.