510(k) K093054

SCALP DURA RETRACTOR, MODEL KS00474 by KARL STORZ Endoscopy-America, Inc. — Product Code GZT

K093054 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "SCALP DURA RETRACTOR, MODEL KS00474". The FDA issued a decision of Substantially Equivalent on November 15, 2010. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.