Obstetrics/Gynecology · 12 clearances · 12 unique sponsors
| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Guangzhou Hehong Biotech Co., Ltd. | 1 | 0 | 2025-02-03 |
| Allwin Medical Devices, Inc. | 1 | 0 | 2021-06-04 |
| Hertart Aps | 1 | 0 | 2020-12-16 |
| Bonraybio Co., Ltd. | 1 | 0 | 2022-10-31 |
| Cook Incorporated | 1 | 0 | 2024-03-08 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | 1 | 0 | 2024-06-14 |
| Fujifilm Irvine Scientific | 1 | 0 | 2024-09-26 |
| Motilitycount Aps | 1 | 0 | 2025-01-31 |
| Origio A/S | 1 | 0 | 2020-06-25 |
| Ipreg Incorporation | 1 | 0 | 2025-02-20 |
| Cytoswim, Ltd. | 1 | 0 | 2024-03-14 |
| Vitrolife A/S | 1 | 0 | 2022-03-11 |
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 |
|---|---|---|---|---|
| A4290 | HCPCS | Sacral nerve stimulation test lead, each ✓ CMS-verified description | Medium | Labware (i.e., beaker, petri dish, flask, etc.), assisted reproduction, per item |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2025-02-20 | K241626 | Ipreg Incorporation | SperSort Sperm Sorting Chip (IPG02) |
| 2025-02-03 | K241454 | Guangzhou Hehong Biotech Co., Ltd. | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) |
| 2025-01-31 | K241348 | Motilitycount Aps | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) |
| 2024-09-26 | K241341 | Fujifilm Irvine Scientific | cryo-GO Vitrification Device |
| 2024-06-14 | K240002 | Gimbo Medical Technology Shenzhen Co., Ltd. | G-Vitri Vitrification Straw |
| 2024-03-14 | K232980 | Cytoswim, Ltd. | SpermAlign Sperm Separation Device |
| 2024-03-08 | K233177 | Cook Incorporated | Nest VT Vitrification Device |
| 2022-10-31 | K221810 | Bonraybio Co., Ltd. | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device |
| 2022-03-11 | K213869 | Vitrolife A/S | EmbryoSlide+ ic8 dish |
| 2021-06-04 | K203626 | Allwin Medical Devices, Inc. | SureStrip Vitrification Straw, SureLock Vitrification Straw |
| 2020-12-16 | K201213 | Hertart Aps | Pasteur Pipette 3mL, Pasteur Pipette 1mL |
| 2020-06-25 | K200815 | Origio A/S | VitriGuard |