Plymouth, MN, US · 4 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HRX | Arthroscope | Class II | Orthopedic | 2 | 2026-05-26 |
| GWG | — | — | — | 2 | 2023-11-21 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-07-27 | Class II | Terminated | Z-2405-2021 | Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002 | — | The sterile barrier seal may be compromised. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-26 | K252790 | Digital ClarusScope System and Digital NeuroPEN System | HRX | Class II | Orthopedic |
| 2024-04-25 | K240535 | Digital ClarusScope System; Digital NeuroPEN System | HRX | Class II | Orthopedic |
| 2023-11-21 | K223615 | Digital ClarusScope System, Digital NeuroPEN System | GWG | — | — |
| 2021-03-18 | K200925 | Clarus Peel-Away Introducer Sheath | GWG | — | — |