meddevicedb.com FDA Device Reference

XSTAT

DEN130016 Class II Direct
Decision Date
2014-04-03
Sponsor / Applicant
Revmedx, Inc.

Technical Specification

510(k) Submission ID DEN130016
Product Code PGZ
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4452
Decision Date 2014-04-03
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

XSTAT received FDA 510(k) clearance under submission number DEN130016, sponsored by Revmedx, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2014-04-03.

Classification & Regulation

This clearance is catalogued under FDA product code PGZ and 21 CFR 878.4452, within the General, Plastic Surgery review panel as a Class II device.