OAB · Low Energy Direct Current Thermal Ablation System
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | OAB |
|---|---|
| Device Name | Low Energy Direct Current Thermal Ablation System |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification Rationale
Class II.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253198 | NanoKnife Generator (H78720300351US0) | Angiodynamics | Mar 24, 2026 | SESE |
| 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. | Dec 6, 2024 | SESE |
| K240376 | Electroporation System (N3000) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Oct 4, 2024 | SESE |
| K233884 | INUMI Flex Needle | Galvanize Therapeutics, Inc. | May 22, 2024 | SESE |
| K240297 | Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) | Us Medical Innovations, LLC | May 3, 2024 | SESE |
| K222001 | Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe | Zhejiang Curaway Medical Technology Co., Ltd. | Jun 8, 2023 | SESE |
| K212871 | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode | Galvanize Therapeutics, Inc. | Jun 17, 2022 | SESE |
| K183385 | NanoKnife System | Angiodynamics | Jun 18, 2019 | SESE |
| K150089 | NanoKnife System | AngioDynamics, Inc. | Jun 18, 2015 | SESE |
| K102329 | NANOKNIFE SYSTEM | AngioDynamics, Inc. | Oct 24, 2011 | SESE |
| K080202 | ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT | Oncobionics, Inc. | May 8, 2008 | SESE |
| K080376 | ONCOBIONIC SYSTEM | Oncobionic Incorporated | Apr 2, 2008 | SESE |
| K060054 | ONCOBIONIC SYSTEM | Oncobionics, Inc. | Nov 21, 2006 | SESE |
Top Applicants
- AngioDynamics, Inc. — 3 clearances
- Oncobionics, Inc. — 2 clearances
- Galvanize Therapeutics, Inc. — 2 clearances
- Angiodynamics — 2 clearances
- Zhejiang Curaway Medical Technology Co., Ltd. — 1 clearance
