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FDA 510(k)

LIXI (LXOSFM1)

K-Number: K253662 · 2026-07-14

ApplicantLuwi, LLC
Decision Date2026-07-14
Product CodeMSC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LIXI (LXOSFM1) is the device name listed in this FDA 510(k) record. The listed applicant is Luwi, LLC. It received FDA 510(k) clearance on 2026-07-14 under 510(k) number K253662. The device is classified under product code MSC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIXI (LXOSFM1)?

LIXI (LXOSFM1) is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Luwi, LLC. The 510(k) number is K253662.

When did LIXI (LXOSFM1) receive FDA 510(k) clearance?

LIXI (LXOSFM1) received FDA 510(k) clearance on 2026-07-14, under 510(k) number K253662.

Who is the listed applicant for LIXI (LXOSFM1)?

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

What is the FDA product code for LIXI (LXOSFM1)?

The FDA product code for LIXI (LXOSFM1) is MSC.

Related Devices (Code: MSC)

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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