NanoKnife Generator (H78720300301US0) +3 more— 510(k) K242687
Substantially EquivalentAngioDynamics, Inc.
FDA 510(k) clearance K242687 for NanoKnife Generator (H78720300301US0) +3 more, Substantially Equivalent on 2024-12-06. Applicant: AngioDynamics, Inc.. Device class: 2.
Clearance details
- Device name as filed
- NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)
- Applicant
- AngioDynamics, Inc.
- Product code
- Code OAB
- 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
- Marlborough, MA, US
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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.