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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 the device name listed in this FDA 510(k) record. The listed applicant is Li Medical Corporation , Ltd.. It received FDA 510(k) clearance on 2025-11-26 under 510(k) 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. The listed applicant is Li Medical Corporation , Ltd.. The 510(k) number is K252260.

When did RELIEEV HSG Catheter (HSG7FA1) receive FDA 510(k) clearance?

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

Who is the listed applicant for RELIEEV HSG Catheter (HSG7FA1)?

The FDA 510(k) record lists Li Medical Corporation , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Li Medical Corporation , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: LKF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, Inc.K223064ALLY II Uterine Positioning System™ (UPS)CooperSurgical, Inc.

Official Source

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

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