LKF — Cannula, Manipulator/Injector, Uterine Class II
FDA Device Classification
Classification Details
- Product Code
- LKF
- Device Class
- Class II
- Regulation Number
- 884.4530
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253403 | femasys | FemVue® Controlled Saline-Air Device (FSA-300) | December 15, 2025 |
| K252260 | li medical corporation | RELIEEV HSG Catheter (HSG7FA1) | November 26, 2025 |
| K242002 | femasys | FemVue MINI Saline-Air Device | November 22, 2024 |
| K240364 | li medical corporation | RELIEEV Uterine Manipulator Injector (CUMI 5.0) | October 16, 2024 |
| K241693 | femasys | FemChec Controlled Saline-Air Device (FCD-250) | September 6, 2024 |
| K222798 | rejoni | Rejoni Intrauterine Catheter | December 16, 2022 |
| K223064 | coopersurgical | ALLY II Uterine Positioning System (UPS) | October 28, 2022 |
| K220202 | o r company pty | Uterine ElevatOR PRO with OccludOR Balloon | March 31, 2022 |
| K212505 | o r company pty | DUMI ManipulatOR | January 10, 2022 |
| K181770 | cook incorporated | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | March 29, 2019 |
| K180291 | cook incorporated | Cook Silicone Balloon HSG Catheter | October 26, 2018 |
| K180300 | cook incorporated | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | October 26, 2018 |
| K172846 | beijing hangtian kadi technology r and d institute | Uterine Manipulator | June 26, 2018 |
| K171604 | cook incorporated | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterizatio | February 15, 2018 |
| K163214 | clearpath surgical | Unicare System, Unicare Manipulator | February 7, 2017 |
| K160217 | cook incorporated | uVue HSG/SHG Catheter | October 6, 2016 |
| K153092 | coopersurgical | Ally Uterine Positioning System | December 21, 2015 |
| K150519 | gynetech pty. | ManipulatOR PRO, ManipulatOR | August 19, 2015 |
| K142545 | crossbay medical | SonoFlow Sonohysterography and Sonohysterosalpingography Device | March 20, 2015 |
| K143415 | coopersurgical | Air Bubble Based Infuser (ABBI) | February 26, 2015 |