Heylo System
K-Number: K252140 · 2025-10-06
ApplicantColoplast Corp.
Decision Date2025-10-06
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Heylo System is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2025-10-06 under approval number K252140. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Heylo System?
Heylo System is a medical device that received FDA 510(k) clearance on 2025-10-06. It is manufactured by Coloplast Corp.. The 510(k) number is K252140.
When was Heylo System approved by the FDA?
Heylo System received FDA 510(k) clearance on 2025-10-06, under approval number K252140.
What company makes Heylo System?
Heylo System is manufactured by Coloplast Corp..
What is the FDA product code for Heylo System?
The FDA product code for Heylo System is EXB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.