Product code LKF
- 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
- Source
- FDA openFDA device classification dataset
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 |
|---|---|---|---|
| 04719894432922 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894432915 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894432908 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894432892 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894432588 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432939 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432885 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432878 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432762 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432755 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432625 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432618 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432601 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432595 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432571 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432779 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 09349967001028 | DUMI ManipulatOR | THE O R COMPANY PTY LTD | 2022-01-18 |
| 09349967000991 | Uterine ElevatOR PRO with Long Handle | THE O R COMPANY PTY LTD | 2019-09-25 |
| 09349967000960 | Uterine ElevatOR PRO with Long Handle | THE O R COMPANY PTY LTD | 2019-09-25 |
| 09349967000908 | Uterine ElevatOR PRO with Long Handle | THE O R COMPANY PTY LTD | 2019-09-25 |
| 09349967000939 | Uterine ElevatOR PRO with Long Handle | THE O R COMPANY PTY LTD | 2019-09-25 |
| 09349967000816 | Uterine PositionOR Pro | THE O R COMPANY PTY LTD | 2019-06-21 |
| 09349967002759 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | 2018-01-31 |
| 09349967002247 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | 2017-07-19 |
| 09349967002278 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | 2017-07-19 |
| 09349967002308 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | 2017-07-19 |
| 09349967002339 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | 2017-07-19 |
| 09349967000007 | ManipulatOR | SURGI SUPPLIES INTERNATIONAL PTY. LTD. | 2016-11-09 |
| H671MIS50ST0 | TVUS/HSG-Cath | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671MIS50P0 | TVUS/HSG-Cath | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |