MAGENTIQ-COLO (ME-APDS)— 510(k) K244023

Substantially Equivalent

Magentiq Eye, Ltd.

FDA 510(k) clearance K244023 for MAGENTIQ-COLO (ME-APDS), Substantially Equivalent on 2025-01-24. Applicant: Magentiq Eye, Ltd.. Device class: 2.

Clearance details

Applicant: Magentiq Eye, Ltd.
Product code: Code QNP
Device class: Class 2
Regulation: 21 CFR 876.1520
Advisory panel: Gastroenterology, Urology
Date received: 2024-12-27
Decision date: 2025-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

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K260724 — MAGENTIQ-COLO (ME-APDS)2026-04-03

More clearances from Magentiq Eye, Ltd.

K252178 — MAGENTIQ-COLO (ME-APDS)2025-10-03
K223473 — ME-APDS; MAGENTIQ-COLO2023-07-25

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