Agoura Hills, CA, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | Class II | Obstetrics/Gynecology | 3 | 2023-11-30 |
| OTN | — | — | — | 1 | 2021-11-10 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General Hospital | 1 | 2020-07-20 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | Class II | General, Plastic Surgery | 1 | 2020-02-07 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-11-30 | K233500 | Benesta Tissue Removal Device | HIH | Class II | Obstetrics/Gynecology |
| 2021-11-10 | K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System | OTN | — | — |
| 2020-10-23 | K192811 | BenestaTM Tissue Removal Device | HIH | Class II | Obstetrics/Gynecology |
| 2020-09-09 | K192822 | Benesta Hysteroscope | HIH | Class II | Obstetrics/Gynecology |
| 2020-07-20 | K193603 | Benesta Medical Sterilization Tray | KCT | Class II | General Hospital |
| 2020-02-07 | K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | PAH | Class II | General, Plastic Surgery |