Gold Anchor
K-Number: K201117 · 2020-06-11
ApplicantNaslund Medical AB
Decision Date2020-06-11
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Gold Anchor is a medical device manufactured by Naslund Medical AB. It received FDA 510(k) clearance on 2020-06-11 under approval number K201117. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gold Anchor?
Gold Anchor is a medical device that received FDA 510(k) clearance on 2020-06-11. It is manufactured by Naslund Medical AB. The 510(k) number is K201117.
When was Gold Anchor approved by the FDA?
Gold Anchor received FDA 510(k) clearance on 2020-06-11, under approval number K201117.
What company makes Gold Anchor?
Gold Anchor is manufactured by Naslund Medical AB.
What is the FDA product code for Gold Anchor?
The FDA product code for Gold Anchor is IYE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.