Cleared Special

SpaceOAR System

K181465 · Augmenix, Inc. · Radiology

Jun 2018

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K181465 is an FDA 510(k) clearance for the SpaceOAR System, a Hydrogel Spacer (Class II — Special Controls, product code OVB), submitted by Augmenix, Inc. (Bedford, US). The FDA issued a Cleared decision on June 25, 2018, 21 days after receiving the submission on June 4, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5725.

Submission Details

510(k) Number	K181465 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2018
Decision Date	June 25, 2018
Days to Decision	21 days
Submission Type	Special
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.