K230056 is an FDA 510(k) clearance for the MiVu™ Esophageal Endo Cap. This device is classified as a Esophageal, Mucosal, Electrical Characterization (Class II - Special Controls, product code QIS).
Submitted by Diversatek Healthcare (Highlands Ranch, US). The FDA issued a Cleared decision on April 25, 2023, 106 days after receiving the submission on January 9, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1450. The Esophageal Tissue Characterization System Is Intended For Obtaining Measurements Of Electrical Properties Within Esophageal Tissue..
| 510(k) Number | K230056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2023 |
| Decision Date | April 25, 2023 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QIS - Esophageal, Mucosal, Electrical Characterization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1450 |
| Definition | The Esophageal Tissue Characterization System Is Intended For Obtaining Measurements Of Electrical Properties Within Esophageal Tissue. |