NanoKnife Generator (H78720300351US0)
FDA 510(k) K253198 · Angiodynamics
510(k) numberK253198
Submission
- Device name
- NanoKnife Generator (H78720300351US0)
- Applicant
- Angiodynamics
Marlborough, MA, US - Received
- September 26, 2025
- Decision date
- March 24, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAB – Low Energy Direct Current Thermal Ablation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Ablation of soft tissue
Other 510(k)s with product code OAB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253846 | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…OAB · Traditional | Hangzhou Ruidi Biotechnology , Ltd. | 08/12/2026SE |
| K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex NeedleOAB · Traditional | Galvanize Therapeutics, Inc. | 05/07/2026SE |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…OAB · Traditional | AngioDynamics, Inc. | 12/06/2024SE |
| K240376 | Electroporation System (N3000)OAB · Traditional | Surgnova Healthcare Technologies (Zhejiang) Co.… | 10/04/2024SE |
| K233884 | INUMI Flex NeedleOAB · Traditional | Galvanize Therapeutics, Inc. | 05/22/2024SE |
| K240297 | Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)OAB · Traditional | Us Medical Innovations, LLC | 05/03/2024SE |
| K222001 | Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeOAB · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 06/08/2023SE |
| K212871 | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) ElectrodeOAB · Traditional | Galvanize Therapeutics, Inc. | 06/17/2022SE |
| K183385 | NanoKnife SystemOAB · Traditional | Angiodynamics | 06/18/2019SE |
| K150089 | NanoKnife SystemOAB · Traditional | AngioDynamics, Inc. | 06/18/2015SE |
More from AngioDynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ · Traditional | 11/24/2025SE |
| K253106 | AngioVac CannulaDWF · Special | 10/24/2025SE |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…OAB · Traditional | 12/06/2024SE |
| K240397 | AlphaVac MMA F1885 System (H787253020)QEZ · Traditional | 04/01/2024SE |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsGEX · Special | 07/20/2023SE |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/27/2023SE |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/07/2023SE |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemQEZ · Traditional | 04/04/2022SE |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 12/03/2021SE |
| K212386 | AngioVac F18 85DWF · Traditional | 09/30/2021SE |
Questions and answers
When was NanoKnife Generator (H78720300351US0) cleared by the FDA?
NanoKnife Generator (H78720300351US0) (K253198) received a 510(k) decision of Substantially Equivalent on March 24, 2026, 179 days after the submission was received.
What is the product code of K253198?
The FDA product code is OAB – Low Energy Direct Current Thermal Ablation System, a Class II (moderate risk) device regulated under 21 CFR 878.4400.