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# Absorbable Perirectal Spacer Into Class 2
- URL: https://www.fdaweb.com/absorbable-perirectal-spacer-into-class-2/
- Published: 2018-01-05T12:00:00.000Z
- Updated: 2026-09-14T23:11:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140432

*Federal Register* notice: FDA has classified the absorbable perirectal spacer into Class 2 (special controls). The action is in response to a 10/14 *de novo* classification request by Augmenix, Inc. for its SpaceOAR System. The agency has named the generic type of device absorbable perirectal spacer, and it is identified as a device composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum. The absorbable spacer maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-01-05/pdf/2018-00051.pdf?ref=fdaweb.com).