510(k) K946332

KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION by KARL STORZ Endoscopy-America, Inc. — Product Code EQJ

K946332 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION". The FDA issued a decision of Substantially Equivalent on June 5, 1995. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.