OAB
- Product code
- OAB
- Device name
- Low Energy Direct Current Thermal Ablation System
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 15 (all years; only the last 3 years are listed here)
FDA classification definition
Ablation of soft tissue
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253846 | 2026-08-12 | Hangzhou Ruidi Biotechnology , Ltd. | Steep Pulse Ablation Instrument (including Disposabl… | |
| K253826 | 2026-05-07 | Galvanize Therapeutics, Inc. | Aliya® EX System; Aliya® EX Generator; Aliya® Needle… | |
| K253198 | 2026-03-24 | Angiodynamics | NanoKnife Generator (H78720300351US0) | FDA |
| K242687 | 2024-12-06 | AngioDynamics, Inc. | NanoKnife Generator (H78720300301US0); NanoKnife Sin… | |
| K240376 | 2024-10-04 | Surgnova Healthcare Technologies (Zhej… | Electroporation System (N3000) | |
| K233884 | 2024-05-22 | Galvanize Therapeutics, Inc. | INUMI Flex Needle | |
| K240297 | 2024-05-03 | Us Medical Innovations, LLC | Canady Helios Cold Plasma XL-1000CP Ablation Syste… |
Official FDA classification page: OAB
Classification and pathway per current FDA publications. Data from openFDA (CC0).