OAB · Class II · 21 CFR 878.4400

FDA Product Code OAB: Low Energy Direct Current Thermal Ablation System

Ablation Of Soft Tissue

Leading manufacturers include AngioDynamics, Inc., Galvanize Therapeutics, Inc. and Oncobionics, Inc..

15
Total
15
Cleared
203d
Avg days
2006
Since
Stable submission activity - 4 submissions in the last 2 years
Review times improving: avg 170d recently vs 215d historically

FDA 510(k) Cleared Low Energy Direct Current Thermal Ablation System Devices (Product Code OAB)

15 devices
1–15 of 15
Cleared Aug 12, 2026
Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02)
K253846
Hangzhou Ruidi Biotechnology , Ltd.
General & Plastic Surgery · 253d
Cleared May 07, 2026
Aliya® EX System
K253826
Galvanize Therapeutics, Inc.
General & Plastic Surgery · 157d
Cleared Mar 24, 2026
NanoKnife Generator (H78720300351US0)
K253198
Angiodynamics
Gastroenterology & Urology · 179d
Cleared Dec 06, 2024
NanoKnife Generator (H78720300301US0)
K242687
AngioDynamics, Inc.
Gastroenterology & Urology · 91d
Cleared Oct 04, 2024
Electroporation System (N3000)
K240376
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
General & Plastic Surgery · 240d
Cleared May 22, 2024
INUMI™ Flex Needle
K233884
Galvanize Therapeutics, Inc.
General & Plastic Surgery · 166d
Cleared May 03, 2024
Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
K240297
Us Medical Innovations, LLC
General & Plastic Surgery · 92d
Cleared Jun 08, 2023
Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
K222001
Zhejiang Curaway Medical Technology Co., Ltd.
General & Plastic Surgery · 336d
Cleared Jun 17, 2022
Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
K212871
Galvanize Therapeutics, Inc.
General & Plastic Surgery · 281d
Cleared Jun 18, 2019
NanoKnife System
K183385
Angiodynamics
General & Plastic Surgery · 194d
Cleared Jun 18, 2015
NanoKnife System
K150089
AngioDynamics, Inc.
General & Plastic Surgery · 153d
Cleared Oct 24, 2011
NANOKNIFE SYSTEM
K102329
AngioDynamics, Inc.
General & Plastic Surgery · 433d
Cleared May 08, 2008
ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
K080202
Oncobionics, Inc.
General & Plastic Surgery · 101d
Cleared Apr 02, 2008
ONCOBIONIC SYSTEM
K080376
Oncobionic Incorporated
General & Plastic Surgery · 50d
Cleared Nov 21, 2006
ONCOBIONIC SYSTEM
K060054
Oncobionics, Inc.
General & Plastic Surgery · 319d

About Product Code OAB - Regulatory Context

510(k) Submission Activity

15 total 510(k) submissions under product code OAB since 2006, with 15 receiving FDA clearance (average review time: 203 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - OAB Product Code

Recent submissions under OAB have taken an average of 170 days to reach a decision - down from 215 days historically, suggesting improved FDA processing for this classification.

OAB devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →