510(k) K023272

DISPOSABLE ASPIRATION NEEDLE NA-200H by The Olympus Optical Co. — Product Code FCG

K023272 is an FDA 510(k) premarket notification submitted by The Olympus Optical Co. for the device "DISPOSABLE ASPIRATION NEEDLE NA-200H". The FDA issued a decision of Substantially Equivalent on December 23, 2002. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. The Olympus Optical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2002
Date Received
October 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type