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

Name: FDA 510(k) clearance K223020
Creator: U.S. Food and Drug Administration
Published: 2022-10-28

Substantially Equivalent

Visionsense, Ltd.

FDA 510(k) clearance K223020 for VS3-Iridium System (VS3-IR), Substantially Equivalent on 2022-10-28. Applicant: Visionsense, Ltd.. Device class: 2.

Clearance details

Applicant: Visionsense, Ltd.
Product code: Code OWN
Device class: Class 2
Regulation: 21 CFR 876.1500
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 ↗

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K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040)2026-02-12

More clearances from Visionsense, Ltd.

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K210265 — VS3 Iridium Sytem2021-11-22
K171208 — Trans-anal Introducer2018-02-05
K153548 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM2016-02-22
K152204 — VS3-IR system2015-10-28
K150018 — VS3-IR-MMS System2015-06-17

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.