K173111

Substantially Equivalent

LAP-iX Suction Irrigation

Applicant: Sejong Medical Co., Ltd.
Product code: HET
Advisory panel: Obstetrics/Gynecology
Date received: 2017-09-29
Decision date: 2017-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paju-Si, KR

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.