DeviceClearance

Product code OVB— Radiology

SpaceOAR System

Classification name
Hydrogel Spacer
Device class
Class 2
Regulation
21 CFR 892.5725
Advisory panel
Radiology
Total cleared
8
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OVB under 21 CFR 892.5725, via openFDA

Market context for product code OVB

FDA has cleared 8 devices under product code OVB between 2015 and 2026, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OVB

Adverse events under product code OVB

product code OVB
Death
7
Injury
658
Malfunction
1,206
Total
1,871

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OVB

Data sourced from openFDA. This site is unofficial and independent of the FDA.