Cleared Traditional

SpaceOAR Vue Hydrogel

K182971 · Augmenix, Inc. · Radiology

Jul 2019

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K182971 is an FDA 510(k) clearance for the SpaceOAR Vue Hydrogel, a Hydrogel Spacer (Class II — Special Controls, product code OVB), submitted by Augmenix, Inc. (Bedford, US). The FDA issued a Cleared decision on July 19, 2019, 266 days after receiving the submission on October 26, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5725.

Submission Details

510(k) Number	K182971 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 26, 2018
Decision Date	July 19, 2019
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OVB — Hydrogel Spacer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.5725
Definition	The Perirectal Spacer Is Intended To Temporarily Position The Anterior Rectal Wall Away From The Prostate During Radiotherapy For Prostate Cancer And In Creating This Space It Is The Intent Of The Perirectal Spacer To Reduce The Radiation Dose Delivered To The Anterior Rectum. The Perirectal Spacer Is Composed Of Biodegradable Material And Maintains Space For The Entire Course Of Prostate Radiotherapy Treatment And Is Completely Absorbed By The Patient?s Body Over Time.