meddevicedb.com FDA Device Reference

Revi System

DEN220073 Class II Direct
Decision Date
2023-08-16
Sponsor / Applicant
Bluewind Medical , Ltd.

Technical Specification

510(k) Submission ID DEN220073
Product Code QXM
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5305
Decision Date 2023-08-16
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

Revi System received FDA 510(k) clearance under submission number DEN220073, sponsored by Bluewind Medical , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-08-16.

Classification & Regulation

This clearance is catalogued under FDA product code QXM and 21 CFR 876.5305, within the Gastroenterology, Urology review panel as a Class II device.