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FDA 510(k)

WRAP System

K-Number: K260050 · 2026-07-15

ApplicantHuneo, LLC
Decision Date2026-07-15
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WRAP System is the device name listed in this FDA 510(k) record. The listed applicant is Huneo, LLC. It received FDA 510(k) clearance on 2026-07-15 under 510(k) number K260050. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WRAP System?

WRAP System is a medical device that received FDA 510(k) clearance on 2026-07-15. The listed applicant is Huneo, LLC. The 510(k) number is K260050.

When did WRAP System receive FDA 510(k) clearance?

WRAP System received FDA 510(k) clearance on 2026-07-15, under 510(k) number K260050.

Who is the listed applicant for WRAP System?

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

What is the FDA product code for WRAP System?

The FDA product code for WRAP System is MNR.

Related Devices (Code: MNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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