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510(k) K200638

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2020
Date Received
March 10, 2020
Clearance Type
Special
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)
  • K173108 — Smoklean (May 18, 2018)
  • K173111 — LAP-iX Suction Irrigation (November 28, 2017)
  • K173112 — LAP-iX (November 21, 2017)
  • K171726 — LapBag (September 25, 2017)
  • K171741 — Laport (August 29, 2017)

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  • K200216 — 4K UHD Camera System (August 21, 2020)
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