DeviceClearance

Product code QXR— Radiology

BrachyGel Vaginal Hydrogel Packing System

Classification name
Vaginal Hydrogel Packing System
Device class
Class 2
Regulation
21 CFR 892.5735
Advisory panel
Radiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. The device 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.”

— U.S. Food and Drug Administration, device classification record for product code QXR under 21 CFR 892.5735, via openFDA

Market context for product code QXR

FDA has cleared 1 device under product code QXR, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QXR

Recent clearances under product code QXR

Data sourced from openFDA. This site is unofficial and independent of the FDA.