Magseed Magnetic Marker System— 510(k) K163541

Name: FDA 510(k) clearance K163541
Creator: U.S. Food and Drug Administration
Published: 2017-01-13

Substantially Equivalent

Endomagnetics Ltd.,

FDA 510(k) clearance K163541 for Magseed Magnetic Marker System, Substantially Equivalent on 2017-01-13. Applicant: Endomagnetics Ltd.,. Device class: 2.

Clearance details

Applicant: Endomagnetics Ltd.,
Product code: Code PBY
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2016-12-16
Decision date: 2017-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Cambridge, GB

Download summary PDF View on FDA.gov ↗

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