LKF
- Product code
- LKF
- Device name
- Cannula, Manipulator/Injector, Uterine
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 87
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253403 | 2025-12-15 | Femasys, Inc. | FemVue® Controlled Saline-Air Device (FSA-300) | |
| K252260 | 2025-11-26 | Li Medical Corporation , Ltd. | RELIEEV HSG Catheter (HSG7FA1) | |
| K242002 | 2024-11-22 | Femasys, Inc. | FemVue MINI Saline-Air Device | |
| K240364 | 2024-10-16 | Li Medical Corporation , Ltd. | RELIEEV Uterine Manipulator Injector (CUMI 5.0) | |
| K241693 | 2024-09-06 | Femasys, Inc. | FemChec Controlled Saline-Air Device (FCD-250) |
Official FDA classification page: LKF
Classification and pathway per current FDA publications. Data from openFDA (CC0).