510(k) K944590

ETHICON DRILL BIT AND DRILL GUIDE by ETHICON, Inc. — Product Code HSZ

K944590 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "ETHICON DRILL BIT AND DRILL GUIDE". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. ETHICON, Inc. has at least 10 other 510(k) clearances on record.