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510(k) K220641

Barrigel Injectable Gel by Palette Life Sciences — Product Code OVB

K220641 is an FDA 510(k) premarket notification submitted by Palette Life Sciences for the device "Barrigel Injectable Gel". The FDA issued a decision of Substantially Equivalent on May 26, 2022. The device falls under product code OVB (Hydrogel Spacer), a Class II device regulated under 21 CFR 892.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2022
Date Received
March 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hydrogel Spacer
Device Class
Class II
Regulation Number
892.5725
Review Panel
RA
Submission Type

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.

Other clearances for product code OVB

  • K262151 — SpaceOAR Flex™ System (September 11, 2026)
  • K260119 — SpaceOAR Vue System (SV-2101) (February 10, 2026)
  • K222972 — BioProtect Balloon Implant™ System (August 25, 2023)
  • K202224 — SpaceOAR System (August 28, 2020)
  • K182971 — SpaceOAR Vue Hydrogel (July 19, 2019)
  • K181465 — SpaceOAR System (June 25, 2018)
  • DEN140030 — SpaceOAR System (April 1, 2015)

FDA data resources