510(k) K021962

OLYMPUS ULTRASONIC SURGICAL SYSTEM by The Olympus Optical Co. — Product Code LFL

K021962 is an FDA 510(k) premarket notification submitted by The Olympus Optical Co. for the device "OLYMPUS ULTRASONIC SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on February 12, 2003. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. The Olympus Optical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2003
Date Received
June 14, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type