NanoKnife Generator (H78720300351US0)
FDA 510(k) clearance K253198 · decided 2026-03-24
Clearance details
- K-number
- K253198
- Device name
- NanoKnife Generator (H78720300351US0)
- Applicant
- Angiodynamics
- Decision
- Substantially Equivalent
- Date received
- 2025-09-26
- Decision date
- 2026-03-24
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- OAB
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle (K253826) | Galvanize Therapeutics, Inc. | 2026-05-07 |
| 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) (K242687) | AngioDynamics, Inc. | 2024-12-06 |
| Electroporation System (N3000) (K240376) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2024-10-04 |
| INUMI™ Flex Needle (K233884) | Galvanize Therapeutics, Inc. | 2024-05-22 |
| Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) (K240297) | Us Medical Innovations, LLC | 2024-05-03 |
| Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe (K222001) | Zhejiang Curaway Medical Technology Co., Ltd. | 2023-06-08 |
| Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode (K212871) | Galvanize Therapeutics, Inc. | 2022-06-17 |
| NanoKnife System (K183385) | Angiodynamics | 2019-06-18 |
| NanoKnife System (K150089) | AngioDynamics, Inc. | 2015-06-18 |
| NANOKNIFE SYSTEM (K102329) | AngioDynamics, Inc. | 2011-10-24 |
| ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT (K080202) | Oncobionics, Inc. | 2008-05-08 |
| ONCOBIONIC SYSTEM (K080376) | Oncobionic Incorporated | 2008-04-02 |
Recalls involving this device
No recalls on record reference this clearance.