Heylo System— 510(k) K252140

Name: FDA 510(k) clearance K252140
Creator: U.S. Food and Drug Administration
Published: 2025-10-06

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K252140 for Heylo System, Substantially Equivalent on 2025-10-06. Applicant: Coloplast Corp.. Device class: 1.

Clearance details

Applicant: Coloplast Corp.
Product code: Code EXB
Device class: Class 1
Regulation: 21 CFR 876.5900
Advisory panel: Gastroenterology, Urology
Date received: 2025-07-08
Decision date: 2025-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EXB

product code EXB

Injury: 145
Total: 145

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.