LoFric Origo Pro Coudé— 510(k) K261658
Substantially EquivalentWellspect AB
FDA 510(k) clearance K261658 for LoFric Origo Pro Coudé, Substantially Equivalent on 2026-07-17. Applicant: Wellspect AB. Device class: 2.
Summary
Wellspect's LoFric Origo Pro Coudé is filed under EZD, straight catheters. The record doesn't give sizes or materials.
Class II, 21 CFR 876.5130. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Special 510(k).
Wellspect filed from Mölndal, Sweden. Review took 59 calendar days (May 19 to July 17, 2026).
Clearance details
- Applicant
- Wellspect AB
- Product code
- Product code EZD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mölndal, SE
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More clearances from Wellspect AB
view allAdverse events under product code EZD
product code EZD- Injury
- 864
- Malfunction
- 2,210
- Total
- 3,074
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.