510(k) K033903

MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, by Cook Urological, Inc. — Product Code MQH

K033903 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,". The FDA issued a decision of Substantially Equivalent on January 16, 2004. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.