RELIEEV Uterine Manipulator Injector (CUMI 5.0)

FDA 510(k) K240364 · Li Medical Corporation , Ltd.

Substantially Equivalent

510(k) numberK240364

Submission

Device name
RELIEEV Uterine Manipulator Injector (CUMI 5.0)
Applicant
Li Medical Corporation , Ltd.
Xizhi Dist., TW
Received
February 6, 2024
Decision date
October 16, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LKF – Cannula, Manipulator/Injector, Uterine
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code LKF

510(k)DeviceApplicantDecision
K253403FemVue® Controlled Saline-Air Device (FSA-300)LKF · Traditional Femasys, Inc.12/15/2025SE
K252260RELIEEV HSG Catheter (HSG7FA1)LKF · Traditional Li Medical Corporation , Ltd.11/26/2025SE
K242002FemVue MINI Saline-Air DeviceLKF · Traditional Femasys, Inc.11/22/2024SE
K241693FemChec Controlled Saline-Air Device (FCD-250)LKF · Traditional Femasys, Inc.09/06/2024SE
K222798Rejoni Intrauterine CatheterLKF · Traditional Rejoni, Inc.12/16/2022SE
K223064ALLY II Uterine Positioning System™ (UPS)LKF · Special CooperSurgical, Inc.10/28/2022SE
K220202Uterine ElevatOR PRO with OccludOR BalloonLKF · Traditional The O R Company Pty, Ltd.03/31/2022SE
K212505DUMI ManipulatORLKF · Traditional The O R Company Pty, Ltd.01/10/2022SE
K181770Intrauterine Access Balloon Catheter, Selective Salpingography CatheterLKF · Traditional Cook Incorporated03/29/2019SE
K180300Margolin HSG Cannula, Goldstein Sonohysterography CatheterLKF · Traditional Cook Incorporated10/26/2018SE

More from Cook Incorporated

510(k)DeviceDecision
K252260RELIEEV HSG Catheter (HSG7FA1)LKF · Traditional 11/26/2025SE
K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)HHK · Traditional 09/25/2024SE

Questions and answers

When was RELIEEV Uterine Manipulator Injector (CUMI 5.0) cleared by the FDA?

RELIEEV Uterine Manipulator Injector (CUMI 5.0) (K240364) received a 510(k) decision of Substantially Equivalent on October 16, 2024, 253 days after the submission was received.

What is the product code of K240364?

The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.