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510(k) K173111

LAP-iX Suction Irrigation by Sejong Medical Co., Ltd. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2017
Date Received
September 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

Other clearances by Sejong Medical Co., Ltd.

  • K200639 — LAP-iX (September 29, 2021)
  • K200638 — LAP-iX Suction Irrigation (April 3, 2020)
  • K173108 — Smoklean (May 18, 2018)
  • K173112 — LAP-iX (November 21, 2017)
  • K171726 — LapBag (September 25, 2017)
  • K171741 — Laport (August 29, 2017)

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  • K243821 — i-Cut (April 25, 2025)
  • K221642 — SIRIUS Endoscope System (December 12, 2022)
  • K210116 — Video Endoscopy System, 3D Video Endoscopy System (October 13, 2021)
  • K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 (September 17, 2021)
  • K210104 — SurroundScope System (July 8, 2021)
  • K201617 — TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera (March 12, 2021)
  • K200216 — 4K UHD Camera System (August 21, 2020)
  • K200638 — LAP-iX Suction Irrigation (April 3, 2020)
  • K190190 — WV1 Endoscope (November 1, 2019)