Minneapolis, MN, US · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | Class II | Gastroenterology, Urology | 1 | 2023-08-14 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 1 | 2023-03-01 |
| FEB | Accessories, Cleaning, For Endoscope | Class II | Gastroenterology, Urology | 1 | 2022-01-14 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-04-20 | Class II | Terminated | Z-1859-2021 | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible… | — | The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-08-14 | K231418 | ENDOGATOR Hybrid Irrigation Tubing | OCX | Class II | Gastroenterology, Urology |
| 2023-03-01 | K223040 | Endo SmartCap | FAJ | Class II | Gastroenterology, Urology |
| 2022-01-14 | K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | FEB | Class II | Gastroenterology, Urology |