K252140
- 510(k) number
- K252140
- Device name
- Heylo System
- Applicant
- Coloplast Corp. MN · US
- Product code
- EXB — Collector, Ostomy
- Decision date
- 2025-10-06
- Date received
- 2025-07-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252140.pdf
Official FDA record: K252140
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.