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BrachyGel Vaginal Hydrogel Packing System

by Brachyfoam, Inc. D/B/A Advaray 510(k)

Active United States

510(k) DEN220052

Overview

A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. It is intended to reduce the radiation dose delivered to adjacent pelvic organs by temporarily displacing the vaginal wall and adjacent pelvic tissues during radiation therapy treatment planning and delivery.

The device is supplied as a personalized packing solution for image-guided brachytherapy. It contours to the patient's anatomy and reduces air gaps compared to gauze or saline-filled balloons, providing proven stability of brachytherapy applicators through treatment planning and delivery.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN220052 Date22 Aug 2023DecidedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA De Novo Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
QXR
Device Class
Class II
Regulation
21 CFR Part 892.5735
Advisory Committee
Radiology
FDA Decision
DENG De Novo granted

Questions

  • What is the BrachyGel Vaginal Hydrogel Packing System used for?

    It is used to temporarily displace the vaginal wall and adjacent pelvic tissues during radiation therapy treatment planning and delivery, reducing radiation dose to nearby pelvic organs by improving the positioning and stability of brachytherapy applicators.

  • How is the BrachyGel system supplied and is it reusable?

    The device is supplied as a personalized packing solution for individual patients, consisting of a flexible container pre-filled with hydrogel; it is intended for single-use only and should not be reused due to hygiene, material integrity, and positioning accuracy concerns.

  • What materials make up the BrachyGel device and how does it conform to anatomy?

    The system consists of a flexible container filled with a hydrogel that conforms to the patient's anatomy, reducing air gaps compared to traditional gauze or saline-filled balloons and providing stable positioning of applicators throughout treatment.