SpaceOAR System
FDA 510(k) K202224 · Boston Scientific Corporation
510(k) numberK202224
Submission
- Device name
- SpaceOAR System
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- August 7, 2020
- Decision date
- August 28, 2020
- 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 |
| K182971 | SpaceOAR Vue HydrogelOVB · Traditional | Augmenix, Inc. | 07/19/2019SE |
| K181465 | SpaceOAR SystemOVB · Special | Augmenix, Inc. | 06/25/2018SE |
More from Augmenix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262151 | SpaceOAR Flex SystemOVB · Traditional | 09/11/2026SE |
| K262460 | Rezum SystemKNS · Traditional | 09/03/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | 08/26/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | 08/21/2026SE |
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | 08/12/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | 08/04/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | 07/24/2026SE |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | 07/24/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | 07/10/2026SE |
Questions and answers
When was SpaceOAR System cleared by the FDA?
SpaceOAR System (K202224) received a 510(k) decision of Substantially Equivalent on August 28, 2020, 21 days after the submission was received.
What is the product code of K202224?
The FDA product code is OVB – Hydrogel Spacer, a Class II (moderate risk) device regulated under 21 CFR 892.5725.