NanoKnife System— 510(k) K183385
Substantially EquivalentAngiodynamics
FDA 510(k) clearance K183385 for NanoKnife System, Substantially Equivalent on 2019-06-18. Applicant: Angiodynamics.
Clearance details
- Applicant
- Angiodynamics
- Product code
- Code OAB
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Adverse events under product code OAB
product code OAB- Death
- 5
- Total
- 5
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.