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FDA 510(k)

RELIEEV HSG Catheter (HSG7FA1)

K-Number: K252260 · 2025-11-26

ApplicantLi Medical Corporation , Ltd.
Decision Date2025-11-26
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RELIEEV HSG Catheter (HSG7FA1) is a medical device manufactured by Li Medical Corporation , Ltd.. It received FDA 510(k) clearance on 2025-11-26 under approval number K252260. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RELIEEV HSG Catheter (HSG7FA1)?

RELIEEV HSG Catheter (HSG7FA1) is a medical device that received FDA 510(k) clearance on 2025-11-26. It is manufactured by Li Medical Corporation , Ltd.. The 510(k) number is K252260.

When was RELIEEV HSG Catheter (HSG7FA1) approved by the FDA?

RELIEEV HSG Catheter (HSG7FA1) received FDA 510(k) clearance on 2025-11-26, under approval number K252260.

What company makes RELIEEV HSG Catheter (HSG7FA1)?

RELIEEV HSG Catheter (HSG7FA1) is manufactured by Li Medical Corporation , Ltd..

What is the FDA product code for RELIEEV HSG Catheter (HSG7FA1)?

The FDA product code for RELIEEV HSG Catheter (HSG7FA1) is LKF.

Other Devices by Li Medical Corporation , Ltd.

K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0) K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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