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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Wellspect AB. It received FDA 510(k) clearance on 2025-09-26 under 510(k) 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. The listed applicant is Wellspect AB. The 510(k) number is K250659.

When did LoFric Origo receive FDA 510(k) clearance?

LoFric Origo received FDA 510(k) clearance on 2025-09-26, under 510(k) number K250659.

Who is the listed applicant for LoFric Origo?

The FDA 510(k) record lists Wellspect AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LoFric Origo?

The FDA product code for LoFric Origo is EZD.

Other records listing Wellspect AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261658LoFric Origo Pro CoudéK260999LoFric Elle Pro

Related Devices (Code: EZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister IncorporatedK260999LoFric Elle ProWellspect AB

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.

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