510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181465Substantially Equivalent

SpaceOAR System

Augmenix, Inc., Bedford MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181465 is the FDA 510(k) clearance record for SpaceOAR System, a class II device, cleared for Augmenix, Inc. on 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 to . As of , FDA records show one recall naming K181465.

Clearance record

Decision date
Received
(21 days to decision)
Product code
OVB Hydrogel Spacer
Regulation
21 CFR 892.5725
Device class
Class II
Review panel
Radiology
Applicant
Augmenix, Inc. 201 Burlington Rd., Bedford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVB

Trailing 12 months
2 clearances under product code OVB in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OVB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260