Clearance Summary
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) received FDA 510(k) clearance under submission number K253846, sponsored by Hangzhou Ruidi Biotechnology , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-08-12.
- Submission: K253846
- Applicant / Sponsor: Hangzhou Ruidi Biotechnology , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2026-08-12
Classification & Regulation
This clearance is catalogued under FDA product code OAB and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.