Cleared Traditional

Barrigel Injectable Gel

K220641 · Palette Life Sciences · Radiology
May 2022
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K220641 is an FDA 510(k) clearance for the Barrigel Injectable Gel, a Hydrogel Spacer (Class II — Special Controls, product code OVB), submitted by Palette Life Sciences (Santa Barbara, US). The FDA issued a Cleared decision on May 26, 2022, 83 days after receiving the submission on March 4, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5725.

Submission Details

510(k) Number K220641 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2022
Decision Date May 26, 2022
Days to Decision 83 days
Submission Type Traditional
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.