LIXI (LXOSFM1)— 510(k) K253662

Substantially Equivalent

Luwi, LLC

FDA 510(k) clearance K253662 for LIXI (LXOSFM1), Substantially Equivalent on 2026-07-14. Applicant: Luwi, LLC.

Clearance details

Applicant: Luwi, LLC
Product code: Code MSC
Advisory panel: Obstetrics/Gynecology
Date received: 2025-11-20
Decision date: 2026-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Prospect, IL, US

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