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510(k) K210567

Ultrasonic Surgical System by Miconvey Technologies Co., Ltd. — Product Code LFL

K210567 is an FDA 510(k) premarket notification submitted by Miconvey Technologies Co., Ltd. for the device "Ultrasonic Surgical System". The FDA issued a decision of Substantially Equivalent on September 30, 2022. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2022
Date Received
February 26, 2021
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 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