FDA 510(k)

Heylo™ System

K-Number: K252140 · 2025-10-06

Decision Date2025-10-06

Product CodeEXB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Heylo™ System is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2025-10-06 under 510(k) 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. The listed applicant is Coloplast Corp.. The 510(k) number is K252140.

When did Heylo™ System receive FDA 510(k) clearance?

Heylo™ System received FDA 510(k) clearance on 2025-10-06, under 510(k) number K252140.

Who is the listed applicant for Heylo™ System?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heylo™ System?

The FDA product code for Heylo™ System is EXB.

Other records listing Coloplast Corp. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.