RELIEEV HSG Catheter (HSG7FA1)— 510(k) K252260

Substantially Equivalent

Li Medical Corporation , Ltd.

FDA 510(k) clearance K252260 for RELIEEV HSG Catheter (HSG7FA1), Substantially Equivalent on 2025-11-26. Applicant: Li Medical Corporation , Ltd..

Clearance details

Applicant: Li Medical Corporation , Ltd.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2025-07-21
Decision date: 2025-11-26
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.