# K220641: Barrigel Injectable Gel

- Pathway: 510(k) (Traditional)
- Applicant: Palette Life Sciences
- Decided: May 26, 2022 after 83 days
- Product code: OVB (Hydrogel Spacer)
- Device class: 2
- Regulation: 21 CFR 892.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN140030 (2015). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202224: SpaceOAR System, Boston Scientific Corporation (2020) Summary page 4.

## Indications for use
Barrigel 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 Barrigel to reduce the radiation dose delivered to the anterior rectum. Barrigel is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient's body over time.

Source page: https://510kreport.com/device/K220641
Methodology: https://510kreport.com/methodology