510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220052Unknown

BrachyGel Vaginal Hydrogel Packing System

Brachyfoam, Inc. D/B/A Advaray, Charlottesville VA / Direct, Unknown
FDA source (opens on fda.gov)

DEN220052 is the FDA 510(k) clearance record for BrachyGel Vaginal Hydrogel Packing System, a class II device, cleared for Brachyfoam, Inc. D/B/A Advaray on under FDA product code QXR (Vaginal Hydrogel Packing System). FDA's definition for product code QXR reads: "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...". FDA records list one 510(k) clearance for Brachyfoam, Inc. D/B/A Advaray. As of , FDA records show no recalls naming DEN220052.

Clearance record

Decision date
Received
(362 days to decision)
Product code
QXR Vaginal Hydrogel Packing System
Regulation
21 CFR 892.5735
Device class
Class II
Review panel
Radiology
Applicant
Brachyfoam, Inc. D/B/A Advaray 722 Preston Ave. Suite 108, Charlottesville VA
Third party review
No

Clearances, product code QXR

Trailing 12 months

FDA records hold no clearances under product code QXR in the trailing twelve months.

FDA records show no clearances under product code QXR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260