Product code LKF
Current FDA Classification
- Device name
- Cannula, Manipulator/Injector, Uterine
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. | 2025-12-15 |
| K252260 | RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. | 2025-11-26 |
| K242002 | FemVue MINI Saline-Air Device | Femasys, Inc. | 2024-11-22 |
| K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0) | Li Medical Corporation , Ltd. | 2024-10-16 |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250) | Femasys, Inc. | 2024-09-06 |
| K222798 | Rejoni Intrauterine Catheter | Rejoni, Inc. | 2022-12-16 |
| K223064 | ALLY II Uterine Positioning System (UPS) | CooperSurgical, Inc. | 2022-10-28 |
| K220202 | Uterine ElevatOR PRO with OccludOR Balloon | The O R Company Pty, Ltd. | 2022-03-31 |
| K212505 | DUMI ManipulatOR | The O R Company Pty, Ltd. | 2022-01-10 |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | Cook Incorporated | 2019-03-29 |
| K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | Cook Incorporated | 2018-10-26 |
| K180291 | Cook Silicone Balloon HSG Catheter | Cook Incorporated | 2018-10-26 |
| K172846 | Uterine Manipulator | Beijing Hangtian Kadi Technology R&D Institute | 2018-06-26 |
| K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip | Cook Incorporated | 2018-02-15 |
| K163214 | Unicare System, Unicare Manipulator | Clearpath Surgical, Inc. | 2017-02-07 |
| K160217 | uVue HSG/SHG Catheter | Cook Incorporated | 2016-10-06 |
| K153092 | Ally Uterine Positioning System | CooperSurgical, Inc. | 2015-12-21 |
| K150519 | ManipulatOR PRO, ManipulatOR | Gynetech Pty. , Ltd. | 2015-08-19 |
| K142545 | SonoFlow Sonohysterography and Sonohysterosalpingography Device | Crossbay Medical, Inc. | 2015-03-20 |
| K143415 | Air Bubble Based Infuser (ABBI) | CooperSurgical, Inc. | 2015-02-26 |
| K142716 | VCARE | Conmed Corporation | 2015-02-10 |
| K142164 | MANIPULATOR; MANIPULATOR PRO | Gynetech Pty. , Ltd. | 2014-12-17 |
| K141523 | ALLY UPS | CooperSurgical, Inc. | 2014-11-25 |
| K131781 | CLEARVIEW TOTAL | Clinical Innovations, LLC | 2014-05-28 |
| K130758 | KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER | Kronner Prototypes, Inc. | 2013-12-11 |
| K122820 | VIKY UP | Endocontrol | 2013-06-18 |
| K123258 | THE ADVANCE CATHETER FOR HSG AND SIS | Catheter Research, Inc. | 2013-01-31 |
| K102898 | BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE | Panpac Medical Corporation | 2011-12-15 |
| K110993 | FEMCHEC PRESSURE MANAGEMET DEVICE | Femasys, Inc. | 2011-10-12 |
| K110288 | FEMVUE SALINE-AIR DEVICE | Femasys, Inc. | 2011-04-28 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30859500005005 | FemVue | FEMASYS INC. | 2026-01-06 |
| 20859500005008 | FemVue | FEMASYS INC. | 2026-01-06 |
| 00198506017919 | ELMED INCORPORATED | ELMED INCORPORATED | 2025-08-11 |
| 10860010540937 | Rejoni Ribbed Catheter | Rejoni, Inc. | 2025-02-18 |
| 00840306836022 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306836053 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306836046 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306835902 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306835896 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306835889 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306835872 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306835544 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306835407 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306835391 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306835384 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306835377 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306835360 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00840306835865 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2025-02-12 |
| 00198506074264 | ELMED INCORPORATED | ELMED INCORPORATED | 2025-01-15 |
| 00198506017858 | ELMED INCORPORATED | ELMED INCORPORATED | 2025-01-10 |
| 04719894432977 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894433004 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894432991 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894432984 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | 2024-12-06 |
| 00198506017827 | ELMED INCORPORATED | ELMED INCORPORATED | 2024-11-14 |
| 00859500005097 | FemChec | FEMASYS INC. | 2024-09-16 |
| 00840306830044 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2024-08-06 |
| 00840306830051 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2024-08-06 |
| 00840306830068 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2024-08-06 |
| 00840306830075 | Marina Medical | MARINA MEDICAL INSTRUMENTS, INC. | 2024-08-06 |