Cleared Traditional

K220641 - Barrigel Injectable Gel (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence.

K220641 · Palette Life Sciences · Radiology device
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Optimized for regulatory review, auditing and printing
May 2022
Decision
83d
Days
Class 2
Risk

K220641 is an FDA 510(k) clearance for the Barrigel Injectable Gel. Classified as Hydrogel Spacer (product code OVB), Class II - Special Controls.

Submitted by Palette Life Sciences (Santa Barbara, US). The FDA issued a Cleared decision on May 26, 2022 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5725 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K220641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 107d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OVB Hydrogel Spacer
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.