Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LoFric Origo Pro Coudé

K-Number: K261658 · 2026-07-17

ApplicantWellspect AB
Decision Date2026-07-17
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LoFric Origo Pro Coudé is the device name listed in this FDA 510(k) record. The listed applicant is Wellspect AB. It received FDA 510(k) clearance on 2026-07-17 under 510(k) number K261658. 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 Pro Coudé?

LoFric Origo Pro Coudé is a medical device that received FDA 510(k) clearance on 2026-07-17. The listed applicant is Wellspect AB. The 510(k) number is K261658.

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

LoFric Origo Pro Coudé received FDA 510(k) clearance on 2026-07-17, under 510(k) number K261658.

Who is the listed applicant for LoFric Origo Pro Coudé?

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 Pro Coudé?

The FDA product code for LoFric Origo Pro Coudé 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.

K260999LoFric Elle ProK250659LoFric Origo

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.

K262045Luja 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 ABK252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenConvatec LimitedK260502Liv Pre-lubricated Intermittent CatheterHR Healthcare

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.

↑