WRAP System— 510(k) K260050

Substantially Equivalent

Huneo, LLC

FDA 510(k) clearance K260050 for WRAP System, Substantially Equivalent on 2026-07-15. Applicant: Huneo, LLC.

Clearance details

Applicant: Huneo, LLC
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2026-01-07
Decision date: 2026-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Willoughby Hills, OH, US

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