LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE— 510(k) K140495
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K140495 for LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE, Substantially Equivalent on 2014-04-17. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
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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.