| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Femasys, Inc. | 3 | 1 | 2025-12-15 |
| The O R Company Pty, Ltd. | 2 | 0 | 2022-03-31 |
| Li Medical Corporation , Ltd. | 2 | 1 | 2025-11-26 |
| Rejoni, Inc. | 1 | 0 | 2022-12-16 |
| CooperSurgical, Inc. | 1 | 0 | 2022-10-28 |
Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
|---|---|---|---|---|
| 58346 | CPT | — | Medium | Insertion of uterine device; manipulator/injector for intrauterine procedures |
| A4270 | HCPCS | Disposable endoscope sheath, each ✓ CMS-verified description | Low | Applicator with medication; may cover cannula supplies |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2025-12-15 | K253403 | Femasys, Inc. | FemVue® Controlled Saline-Air Device (FSA-300) |
| 2025-11-26 | K252260 | Li Medical Corporation , Ltd. | RELIEEV HSG Catheter (HSG7FA1) |
| 2024-11-22 | K242002 | Femasys, Inc. | FemVue MINI Saline-Air Device |
| 2024-10-16 | K240364 | Li Medical Corporation , Ltd. | RELIEEV Uterine Manipulator Injector (CUMI 5.0) |
| 2024-09-06 | K241693 | Femasys, Inc. | FemChec Controlled Saline-Air Device (FCD-250) |
| 2022-12-16 | K222798 | Rejoni, Inc. | Rejoni Intrauterine Catheter |
| 2022-10-28 | K223064 | CooperSurgical, Inc. | ALLY II Uterine Positioning System (UPS) |
| 2022-03-31 | K220202 | The O R Company Pty, Ltd. | Uterine ElevatOR PRO with OccludOR Balloon |
| 2022-01-10 | K212505 | The O R Company Pty, Ltd. | DUMI ManipulatOR |