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510(k) K031305

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

K031305 is an FDA 510(k) premarket notification submitted by Olympus Optical Co., Ltd. for the device "OLYMPUS ULTRASONIC SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 23, 2003. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Olympus Optical Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2003
Date Received
April 24, 2003
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

Other clearances by Olympus Optical Co., Ltd.

  • K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND AN (October 16, 2003)
  • K031648 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (July 24, 2003)
  • K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (July 16, 2003)
  • K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 (May 9, 2003)
  • K024138 — HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE (March 12, 2003)
  • K021852 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES (February 11, 2003)
  • K022445 — VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (January 24, 2003)
  • K024033 — XTJF-160AF DUODENOVIDEOSCOPE (December 20, 2002)
  • K023280 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES (December 19, 2002)
  • K013759 — MSS-28CS-301/701 NEEDLESCOPE (August 20, 2002)

Other clearances for product code LFL

  • K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System (October 8, 2025)
  • K242894 — SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultr (June 18, 2025)
  • K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (March 24, 2025)
  • K241700 — Tenex 2nd Generation System (November 18, 2024)
  • K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System (July 11, 2024)
  • K233036 — Ultrasonic Surgical System (June 18, 2024)
  • K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System (July 11, 2023)
  • K231117 — neXus Ultrasonic Surgical Aspirator System (June 23, 2023)
  • K221790 — HARMONIC 700 Shears (February 28, 2023)
  • K223770 — Sonopet 1Q 3 7cm 1Q Large (February 16, 2023)

FDA data resources