510(k) K072594

GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM by Gyrus Acmi, Inc. — Product Code FGA

K072594 is an FDA 510(k) premarket notification submitted by Gyrus Acmi, Inc. for the device "GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 13, 2007. The device falls under product code FGA (Kit, Nephroscope), a Class II device regulated under 21 CFR 876.1500. Gyrus Acmi, Inc. has at least 10 other 510(k) clearances on record.