SpaceOAR System
FDA 510(k) K181465 · Augmenix, Inc.
510(k) numberK181465
Submission
- Device name
- SpaceOAR System
- Applicant
- Augmenix, Inc.
Bedford, MA, US - Received
- June 4, 2018
- Decision date
- June 25, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVB – Hydrogel Spacer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5725
- Specialty
- Radiology
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…
Other 510(k)s with product code OVB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262151 | SpaceOAR Flex SystemOVB · Traditional | Boston Scientific Corporation | 09/11/2026SE |
| K260119 | SpaceOAR Vue System (SV-2101)OVB · Special | Boston Scientific Corporation | 02/10/2026SE |
| K222972 | BioProtect Balloon Implant SystemOVB · Traditional | Bioprotect, Ltd. | 08/25/2023SE |
| K220641 | Barrigel Injectable GelOVB · Traditional | Palette Life Sciences | 05/26/2022SE |
| K202224 | SpaceOAR SystemOVB · Special | Boston Scientific Corporation | 08/28/2020SE |
| K182971 | SpaceOAR Vue HydrogelOVB · Traditional | Augmenix, Inc. | 07/19/2019SE |
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Questions and answers
When was SpaceOAR System cleared by the FDA?
SpaceOAR System (K181465) received a 510(k) decision of Substantially Equivalent on June 25, 2018, 21 days after the submission was received.
What is the product code of K181465?
The FDA product code is OVB – Hydrogel Spacer, a Class II (moderate risk) device regulated under 21 CFR 892.5725.