Company · US
Diversatek Healthcare
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2023. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
7recalls (4 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 2023 | K230056 | MiVu Esophageal Endo Cap Diversatek Healthcare | QIS |
| Nov 8, 2022 | K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing Diversatek Healthcare | OCX |
| Dec 23, 2019 | DEN180067 | Mucosal Integrity Conductivity (MI) Test System Diversatek Healthcare, Inc. | QIS |
| Oct 3, 2019 | K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe Diversatek Healthcare | FFX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2026 | Diversatek Healthcare Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20 Open, Classified |
KNQ | None listed |
| Apr 23, 2026 | Diversatek Healthcare Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18 Open, Classified |
KNQ | None listed |
| Apr 23, 2026 | Diversatek Healthcare Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15 Open, Classified |
KNQ | None listed |
| Apr 23, 2026 | Diversatek Healthcare Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08 Open, Classified |
KNQ | None listed |
| Aug 14, 2025 | Diversatek Healthcare Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 Open, Classified |
FFX | K190208 |
| Sep 7, 2023 | Diversatek Healthcare ZVU Functional GI Software, REF: ZVU-3 Open, Classified |
FFX | K012232 |
| Oct 29, 2021 | Diversatek Healthcare Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointes Terminated |
FGX | None listed |