OAB — Low Energy Direct Current Thermal Ablation System Class II
FDA product code OAB covers "Low Energy Direct Current Thermal Ablation System", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OAB
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Ablation of soft tissue
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253826 | galvanize therapeutics | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI F | May 7, 2026 |
| K253198 | angiodynamics | NanoKnife Generator (H78720300351US0) | March 24, 2026 |
| K242687 | angiodynamics | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Pro | December 6, 2024 |
| K240376 | surgnova healthcare technologies (zhejiang) co | Electroporation System (N3000) | October 4, 2024 |
| K233884 | galvanize therapeutics | INUMI Flex Needle | May 22, 2024 |
| K240297 | us medical innovations | Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) | May 3, 2024 |
| K222001 | zhejiang curaway medical technology co | Irreversible Electroporation Ablation Generator, Irreversible Electroporation Pr | June 8, 2023 |
| K212871 | galvanize therapeutics | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode | June 17, 2022 |
| K183385 | angiodynamics | NanoKnife System | June 18, 2019 |
| K150089 | angiodynamics | NanoKnife System | June 18, 2015 |
| K102329 | angiodynamics | NANOKNIFE SYSTEM | October 24, 2011 |
| K080202 | oncobionics | ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT | May 8, 2008 |
| K080376 | oncobionic incorporated | ONCOBIONIC SYSTEM | April 2, 2008 |
| K060054 | oncobionics | ONCOBIONIC SYSTEM | November 21, 2006 |