510(k) K954238

SURGIN GENISIS HANDPIECE by Surgin Surgical Instrumentation, Inc. — Product Code HQC

K954238 is an FDA 510(k) premarket notification submitted by Surgin Surgical Instrumentation, Inc. for the device "SURGIN GENISIS HANDPIECE". The FDA issued a decision of Substantially Equivalent on December 8, 1995. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Surgin Surgical Instrumentation, Inc. has at least 10 other 510(k) clearances on record.