Diversatek Healthcare
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 4
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2324-2025 | Class III | Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 | June 4, 2025 |
| Z-2521-2023 | Class III | ZVU Functional GI Software, REF: ZVU-3 | July 25, 2023 |
| Z-1771-2022 | Class II | Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endos | October 29, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K230056 | MiVu Esophageal Endo Cap | April 25, 2023 |
| K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing | November 8, 2022 |
| DEN180067 | Mucosal Integrity Conductivity (MI) Test System | December 23, 2019 |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | October 3, 2019 |