Vaginal Hydrogel Packing System

QXR · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.5735

Classification

FDA Product Code: QXR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.5735
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown