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510(k) K031710

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

K031710 is an FDA 510(k) premarket notification submitted by Aomori Olympus Co., Ltd. for the device "OLYMPUS ULTRASONIC SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on August 29, 2003. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Aomori Olympus Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2003
Date Received
June 2, 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 Aomori Olympus Co., Ltd.

  • K042160 — SONOSURG TROCAR (January 25, 2005)
  • K041566 — SONOSURG ULTRASONIC SURGICAL SYSTEM (September 8, 2004)
  • K033333 — SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B (November 14, 2003)
  • K031523 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (October 1, 2003)
  • K021672 — PANCREATIC DRAINAGE TUBE (April 16, 2003)
  • K022446 — MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C (March 28, 2003)

Other clearances for product code LFL

  • K261448 — neXus Ultrasonic Surgical Aspirator System (July 30, 2026)
  • 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)

FDA data resources