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510(k) DEN140030

SpaceOAR System by Augmenix, Inc. — Product Code OVB

DEN140030 is an FDA 510(k) premarket notification submitted by Augmenix, Inc. for the device "SpaceOAR System". The FDA issued a decision of De Novo Granted on April 1, 2015. The device falls under product code OVB (Hydrogel Spacer), a Class II device regulated under 21 CFR 892.5725. Augmenix, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 1, 2015
Date Received
October 1, 2014
Clearance Type
Direct
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 by Augmenix, Inc.

  • K182971 — SpaceOAR Vue Hydrogel (July 19, 2019)
  • K181465 — SpaceOAR System (June 25, 2018)
  • K151998 — TraceIT Tissue Marker - 3mL (August 19, 2015)
  • K121964 — MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML (January 23, 2013)

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)
  • K220641 — Barrigel Injectable Gel (May 26, 2022)
  • K202224 — SpaceOAR System (August 28, 2020)
  • K182971 — SpaceOAR Vue Hydrogel (July 19, 2019)
  • K181465 — SpaceOAR System (June 25, 2018)

FDA data resources