meddevicedb.com FDA Device Reference

BrachyGel Vaginal Hydrogel Packing System

DEN220052 Class II Direct
Decision Date
2023-08-22
Sponsor / Applicant
Brachyfoam, Inc. D/B/A Advaray

Technical Specification

510(k) Submission ID DEN220052
Product Code QXR
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.5735
Decision Date 2023-08-22
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

BrachyGel Vaginal Hydrogel Packing System received FDA 510(k) clearance under submission number DEN220052, sponsored by Brachyfoam, Inc. D/B/A Advaray. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-08-22.

Classification & Regulation

This clearance is catalogued under FDA product code QXR and 21 CFR 892.5735, within the Radiology review panel as a Class II device.