VS3-Iridium System (VS3-IR)— 510(k) K223020

Substantially Equivalent

Visionsense, Ltd.

FDA 510(k) clearance K223020 for VS3-Iridium System (VS3-IR), Substantially Equivalent on 2022-10-28. Applicant: Visionsense, Ltd..

Clearance details

Applicant: Visionsense, Ltd.
Product code: Code OWN
Advisory panel: Gastroenterology, Urology
Date received: 2022-09-29
Decision date: 2022-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Petach Tikva, Hamerkaz, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWN

product code OWN

Malfunction: 1,286
Total: 1,286

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.