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 Patients Body Over Time.
Leading manufacturers include Boston Scientific Corporation.
FDA 510(k) Cleared Hydrogel Spacer Devices (Product Code OVB)
About Product Code OVB - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code OVB since 2015, with 6 receiving FDA clearance (average review time: 133 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under OVB have taken an average of 27 days to reach a decision - down from 151 days historically, suggesting improved FDA processing for this classification.
OVB devices are reviewed by the Radiology panel. Browse all Radiology devices →