RELIEEV Uterine Manipulator Injector (CUMI 5.0)— 510(k) K240364

Substantially Equivalent

Li Medical Corporation , Ltd.

FDA 510(k) clearance K240364 for RELIEEV Uterine Manipulator Injector (CUMI 5.0), Substantially Equivalent on 2024-10-16. Applicant: Li Medical Corporation , Ltd..

Clearance details

Applicant: Li Medical Corporation , Ltd.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2024-02-06
Decision date: 2024-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xizhi Dist., TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

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.