LIXI (LXOSFM1)— 510(k) K253662
Substantially EquivalentLuwi, LLC
FDA 510(k) clearance K253662 for LIXI (LXOSFM1), Substantially Equivalent on 2026-07-14. Applicant: Luwi, LLC. Device class: 2.
Clearance details
- Applicant
- Luwi, LLC
- Product code
- Code MSC
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mount Prospect, IL, US
Recent devices under product code MSC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.