SpaceOAR Vue Hydrogel— 510(k) K182971
Substantially EquivalentAugmenix, Inc.
FDA 510(k) clearance K182971 for SpaceOAR Vue Hydrogel, Substantially Equivalent on 2019-07-19. Applicant: Augmenix, Inc.. Device class: 2.
Clearance details
- Applicant
- Augmenix, Inc.
- Product code
- Code OVB
- Device class
- Class 2
- Regulation
- 21 CFR 892.5725
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code OVB
view allMore clearances from Augmenix, Inc.
view allAdverse events under product code OVB
product code OVB- Death
- 7
- Injury
- 658
- Malfunction
- 1,206
- Total
- 1,871
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K182971
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182971.
Data sourced from openFDA. This site is unofficial and independent of the FDA.