510(k) K952008

KARL STORZ DRILL by KARL STORZ Endoscopy-America, Inc. — Product Code GEY

K952008 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ DRILL". The FDA issued a decision of Substantially Equivalent on July 26, 1995. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.