OVB · Class II · 21 CFR 892.5725

FDA Product Code OVB: Hydrogel Spacer

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.

Leading manufacturers include Boston Scientific Corporation.

1
Total
1
Cleared
27d
Avg days
2026
Since

List of Hydrogel Spacer devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Feb 10, 2026
SpaceOAR Vue System (SV-2101)
K260119
Boston Scientific Corporation
Radiology · 27d

How to use this database

This page lists all FDA 510(k) submissions for Hydrogel Spacer devices (product code OVB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Radiology FDA review panel. Browse all Radiology devices →