El Dorado Hills, CA, US · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PKP | — | — | — | 4 | 2025-12-22 |
| KZH | Introducer, Syringe Needle | Class II | General Hospital | 1 | 2022-10-20 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-22 | K251105 | Tetra (TM-20); Tetra (TM-50) | PKP | — | — |
| 2024-02-16 | K240148 | SCIg60 Infusion System | PKP | — | — |
| 2023-11-28 | K230883 | VersaPump Infusion System | PKP | — | — |
| 2022-10-20 | K213429 | AccuSert Needle Inserter | KZH | Class II | General Hospital |
| 2022-10-13 | K222087 | SCIg60 Infusion System | PKP | — | — |