meddevicedb.com FDA Device Reference

XTRA4

K251320 Traditional
Decision Date
2025-09-11
Sponsor / Applicant
Al.Chi.Mi.A. S.R.L

Technical Specification

510(k) Submission ID K251320
Product Code LYX
Medical Specialty / Panel Unknown
Decision Date 2025-09-11
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

XTRA4 received FDA 510(k) clearance under submission number K251320, sponsored by Al.Chi.Mi.A. S.R.L. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2025-09-11.

Classification & Regulation

This clearance is catalogued under FDA product code LYX , within the Unknown review panel as a device.