Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) → OAB — Low Energy Direct Current Thermal Ablation System

# OAB · Low Energy Direct Current Thermal Ablation System

_General, Plastic Surgery · 21 CFR 878.4400 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB

## Overview

- **Product Code:** OAB
- **Device Name:** Low Energy Direct Current Thermal Ablation System
- **Regulation:** [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K253198.md) | NanoKnife Generator (H78720300351US0) | Angiodynamics | Mar 24, 2026 | SESE |
| [K242687](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K242687.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K240376.md) | Electroporation System (N3000) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Oct 4, 2024 | SESE |
| [K233884](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K233884.md) | INUMI™ Flex Needle | Galvanize Therapeutics, Inc. | May 22, 2024 | SESE |
| [K240297](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K240297.md) | Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) | Us Medical Innovations, LLC | May 3, 2024 | SESE |
| [K222001](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K222001.md) | Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe | Zhejiang Curaway Medical Technology Co., Ltd. | Jun 8, 2023 | SESE |
| [K212871](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K212871.md) | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode | Galvanize Therapeutics, Inc. | Jun 17, 2022 | SESE |
| [K183385](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K183385.md) | NanoKnife System | Angiodynamics | Jun 18, 2019 | SESE |
| [K150089](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K150089.md) | NanoKnife System | AngioDynamics, Inc. | Jun 18, 2015 | SESE |
| [K102329](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K102329.md) | NANOKNIFE SYSTEM | AngioDynamics, Inc. | Oct 24, 2011 | SESE |
| [K080202](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K080202.md) | ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT | Oncobionics, Inc. | May 8, 2008 | SESE |
| [K080376](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K080376.md) | ONCOBIONIC SYSTEM | Oncobionic Incorporated | Apr 2, 2008 | SESE |
| [K060054](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB/K060054.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OAB)

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