NanoKnife Generator (H78720300351US0)— 510(k) K253198
Substantially EquivalentAngiodynamics
FDA 510(k) clearance K253198 for NanoKnife Generator (H78720300351US0), Substantially Equivalent on 2026-03-24. Applicant: Angiodynamics. Device class: 2.
Summary
Angiodynamics' NanoKnife Generator (H78720300351US0) is filed under OAB, low energy direct current thermal ablation systems. The record doesn't describe the generator beyond its name and that code name.
Class II, 21 CFR 878.4400. The Gastroenterology and Urology review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Angiodynamics filed from Marlborough, Massachusetts. The decision came 179 calendar days after FDA received it (September 26, 2025 to March 24, 2026).
Clearance details
- Applicant
- Angiodynamics
- Product code
- Product 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
Recent devices under product code OAB
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- K242687 — NanoKnife Generator (H78720300301US0) +3 more
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- K233884 — INUMI Flex Needle
More clearances from Angiodynamics
view allAdverse 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.