AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches— 510(k) K180848
Substantially EquivalentArthroCare Corporation
FDA 510(k) clearance K180848 for AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches, Substantially Equivalent on 2018-05-01. Applicant: ArthroCare Corporation.
Clearance details
- Applicant
- ArthroCare Corporation
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.