FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
SpaceOAR System
K Number: DEN140030
·
Decision Apr 1, 2015
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
6
Applicant Total
5
Review Days
182
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Basic Information
- Device Name
- SpaceOAR System
- K Number
- DEN140030
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 892.5725
- Medical Specialty
- Radiology
- Decision
- Unknown
- Applicant
- Augmenix, Inc.
- Date Received
- October 1, 2014
- Decision Date
- April 1, 2015
- Product Code
- OVB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OVB | Hydrogel Spacer | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVB), ordered by most recent decision date.
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Barrigel Injectable Gel
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SpaceOAR System
FDA 510(k)
FDA Class 2
·Radiology
SpaceOAR Vue Hydrogel
FDA 510(k)
FDA Class 2
·Radiology
SpaceOAR System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Augmenix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182971 | SpaceOAR Vue Hydrogel | Jul 19, 2019 | Substantially Equivalent |
| K181465 | SpaceOAR System | Jun 25, 2018 | Substantially Equivalent |
| K151998 | TraceIT Tissue Marker - 3mL | Aug 19, 2015 | Substantially Equivalent |
| K121964 | MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML | Jan 23, 2013 | Substantially Equivalent |