Total clearances
3
2022-01-14 → 2023-08-14
Name variants in FDA filings: Medivators / Medivators, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| OCX |
— |
— |
— |
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 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| 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. |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2023-08-14 |
K231418 |
ENDOGATOR Hybrid Irrigation Tubing |
OCX |
— |
— |
| 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 |