Cleared Special

SpaceOAR System

K202224 · Boston Scientific Corporation · Radiology
Aug 2020
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K202224 is an FDA 510(k) clearance for the SpaceOAR System, a Hydrogel Spacer (Class II — Special Controls, product code OVB), submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on August 28, 2020, 21 days after receiving the submission on August 7, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5725.

Submission Details

510(k) Number K202224 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2020
Decision Date August 28, 2020
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.