Flowery Branch, GA, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class II | General, Plastic Surgery | 2 | 2024-11-05 |
| FXX | — | — | — | 1 | 2022-04-07 |
| FYC | Gown, Isolation, Surgical | Class II | General, Plastic Surgery | 1 | 2021-08-26 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-11-05 | K242664 | gentleheel® Adult Incision Device | FMK | Class II | General, Plastic Surgery |
| 2022-05-18 | K220917 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler | FMK | Class II | General, Plastic Surgery |
| 2022-04-07 | K210860 | Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 | FXX | — | — |
| 2021-08-26 | K210131 | ComfortGuard Surgical Isolation Gown | FYC | Class II | General, Plastic Surgery |