Clearance Summary
Heylo System received FDA 510(k) clearance under submission number K252140, sponsored by Coloplast Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-10-06.
- Submission: K252140
- Applicant / Sponsor: Coloplast Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5900
- Decision date: 2025-10-06
Classification & Regulation
This clearance is catalogued under FDA product code EXB and 21 CFR 876.5900, within the Gastroenterology, Urology review panel as a Class I device.