FDA Product Code
FDA Product Code OAB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253846 | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02) | Hangzhou Ruidi Biotechnology , Ltd. | 2026-08-12 | Traditional | PDF ↗ |
| K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle | Galvanize Therapeutics, Inc. | 2026-05-07 | Traditional | PDF ↗ |
| K253198 | NanoKnife Generator (H78720300351US0) | Angiodynamics | 2026-03-24 | Traditional | PDF ↗ |
| K242687 | 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) | AngioDynamics, Inc. | 2024-12-06 | Traditional | PDF ↗ |
| K240376 | Electroporation System (N3000) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2024-10-04 | Traditional | PDF ↗ |
| K233884 | INUMI Flex Needle | Galvanize Therapeutics, Inc. | 2024-05-22 | Traditional | PDF ↗ |
| K240297 | Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) | Us Medical Innovations, LLC | 2024-05-03 | Traditional | PDF ↗ |
| K222001 | Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe | Zhejiang Curaway Medical Technology Co., Ltd. | 2023-06-08 | Traditional | PDF ↗ |
| K212871 | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode | Galvanize Therapeutics, Inc. | 2022-06-17 | Traditional | PDF ↗ |
| K183385 | NanoKnife System | Angiodynamics | 2019-06-18 | Traditional | PDF ↗ |
| K150089 | NanoKnife System | AngioDynamics, Inc. | 2015-06-18 | Traditional | PDF ↗ |
| K102329 | NANOKNIFE SYSTEM | AngioDynamics, Inc. | 2011-10-24 | Traditional | PDF ↗ |
| K080202 | ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT | Oncobionics, Inc. | 2008-05-08 | Special | PDF ↗ |
| K080376 | ONCOBIONIC SYSTEM | Oncobionic Incorporated | 2008-04-02 | Traditional | PDF ↗ |
| K060054 | ONCOBIONIC SYSTEM | Oncobionics, Inc. | 2006-11-21 | Traditional | PDF ↗ |
Product code OAB · Class II · General, Plastic Surgery. Data: openFDA.