LoFric Origo
K-Number: K250659 · 2025-09-26
ApplicantWellspect AB
Decision Date2025-09-26
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
LoFric Origo is a medical device manufactured by Wellspect AB. It received FDA 510(k) clearance on 2025-09-26 under approval number K250659. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LoFric Origo?
LoFric Origo is a medical device that received FDA 510(k) clearance on 2025-09-26. It is manufactured by Wellspect AB. The 510(k) number is K250659.
When was LoFric Origo approved by the FDA?
LoFric Origo received FDA 510(k) clearance on 2025-09-26, under approval number K250659.
What company makes LoFric Origo?
LoFric Origo is manufactured by Wellspect AB.
What is the FDA product code for LoFric Origo?
The FDA product code for LoFric Origo is EZD.
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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.