LAP-iX Suction Irrigation— 510(k) K200638

Name: FDA 510(k) clearance K200638
Creator: U.S. Food and Drug Administration
Published: 2020-04-03

Substantially Equivalent

Sejong Medical Co., Ltd.

FDA 510(k) clearance K200638 for LAP-iX Suction Irrigation, Substantially Equivalent on 2020-04-03. Applicant: Sejong Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sejong Medical Co., Ltd.
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 2020-03-10
Decision date: 2020-04-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Paju-Si, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Sejong Medical Co., Ltd.

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K253165 — LAP-iX2N2026-06-09
K252985 — Laport2026-05-19
K200639 — LAP-iX2021-09-29
K173108 — Smoklean2018-05-18
K173111 — LAP-iX Suction Irrigation2017-11-28

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.