Luja Soft— 510(k) K262045
Substantially EquivalentColoplast A.S.
FDA 510(k) clearance K262045 for Luja Soft, Substantially Equivalent on 2026-07-07. Applicant: Coloplast A.S.. Device class: 2.
Summary
Coloplast's Luja Soft 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. It came in as a Special 510(k).
Coloplast filed from Minneapolis, Minnesota. Review took 20 calendar days (June 17 to July 7, 2026).
Clearance details
- Applicant
- Coloplast A.S.
- 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
- Minneapolis, MN, US
Recent devices under product code EZD
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- K260394 — Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)
- K253295 — Coude Sleeved IC; Coude Plus Sleeved IC
More clearances from Coloplast A.S.
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.