SpaceOAR Vue Hydrogel

K182971 is the FDA 510(k) clearance record for SpaceOAR Vue Hydrogel, a class II device, cleared for Augmenix, Inc. on 2019-07-19 under FDA product code OVB (Hydrogel Spacer). FDA's definition for product code OVB reads: "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...". FDA records list 5 510(k) clearances for Augmenix, Inc., from 2013-01-23 to 2019-07-19. As of 2026-09-10, FDA records show one recall naming K182971.