FDA product code OAB: Low Energy Direct Current Thermal Ablation System
OAB is the FDA product code for low energy direct current thermal ablation system. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 15 510(k) submissions under OAB, 9 in the last five years, from 9 different applicants. The average 510(k) review took 203 days (median 179); 172 days on average over the last three years. FDA has posted 4 recalls for OAB devices, 1 initiated in the last five years.
Definition
Ablation of soft tissue
Classification
| Field | Value |
|---|---|
| Device name | Low Energy Direct Current Thermal Ablation System |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OAB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 194 |
| 2022 | 1 | 281 |
| 2023 | 1 | 336 |
| 2024 | 4 | 147 |
| 2026 | 3 | 196 |
Compare with all 510(k) review times · Search every OAB clearance
Top OAB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Galvanize Therapeutics, Inc. | 3 | 2026-05-07 |
| AngioDynamics, Inc. | 3 | 2024-12-06 |
| Angiodynamics | 2 | 2026-03-24 |
| Oncobionics, Inc. | 2 | 2008-05-08 |
| Hangzhou Ruidi Biotechnology , Ltd. | 1 | 2026-08-12 |
4 more applicants have OAB clearances. See the full list in Caduvo.
Most recent OAB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253846 | Hangzhou Ruidi Biotechnology , Ltd. | 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) | 2026-08-12 | 253 |
| K253826 | Galvanize Therapeutics, Inc. | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle | 2026-05-07 | 157 |
| K253198 | Angiodynamics | NanoKnife Generator (H78720300351US0) | 2026-03-24 | 179 |
| K242687 | AngioDynamics, Inc. | 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) | 2024-12-06 | 91 |
| K240376 | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Electroporation System (N3000) | 2024-10-04 | 240 |
Recalls for OAB devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-03-02.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code OAB?
OAB is the FDA product code for low energy direct current thermal ablation system. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is OAB?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OAB?
Across 15 cleared submissions the average was 203 days from receipt to decision (median 179).
Which companies have the most OAB clearances?
Galvanize Therapeutics, Inc. (3); AngioDynamics, Inc. (3); Angiodynamics (2); Oncobionics, Inc. (2); Hangzhou Ruidi Biotechnology , Ltd. (1).
Have OAB devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2023-03-02.
Next steps
- Run an FDA pathway report with predicate devices for product code OAB
- Run a recall and safety report across every OAB manufacturer
- Watch product code OAB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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