Rejoni Intrauterine Catheter
FDA 510(k) K222798 · Rejoni, Inc.
510(k) numberK222798
Submission
- Device name
- Rejoni Intrauterine Catheter
- Applicant
- Rejoni, Inc.
Bedford, MA, US - Received
- September 16, 2022
- Decision date
- December 16, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300)LKF · Traditional | Femasys, Inc. | 12/15/2025SE |
| K252260 | RELIEEV HSG Catheter (HSG7FA1)LKF · Traditional | Li Medical Corporation , Ltd. | 11/26/2025SE |
| K242002 | FemVue MINI Saline-Air DeviceLKF · Traditional | Femasys, Inc. | 11/22/2024SE |
| K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0)LKF · Traditional | Li Medical Corporation , Ltd. | 10/16/2024SE |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250)LKF · Traditional | Femasys, Inc. | 09/06/2024SE |
| K223064 | ALLY II Uterine Positioning System (UPS)LKF · Special | CooperSurgical, Inc. | 10/28/2022SE |
| K220202 | Uterine ElevatOR PRO with OccludOR BalloonLKF · Traditional | The O R Company Pty, Ltd. | 03/31/2022SE |
| K212505 | DUMI ManipulatORLKF · Traditional | The O R Company Pty, Ltd. | 01/10/2022SE |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography CatheterLKF · Traditional | Cook Incorporated | 03/29/2019SE |
| K180300 | Margolin HSG Cannula, Goldstein Sonohysterography CatheterLKF · Traditional | Cook Incorporated | 10/26/2018SE |
Questions and answers
When was Rejoni Intrauterine Catheter cleared by the FDA?
Rejoni Intrauterine Catheter (K222798) received a 510(k) decision of Substantially Equivalent on December 16, 2022, 91 days after the submission was received.
What is the product code of K222798?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.