K253846

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)

510(k) number: K253846
Device name: 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)
Applicant: Hangzhou Ruidi Biotechnology , Ltd. CN
Product code: OAB — Low Energy Direct Current Thermal Ablation System
Decision date: 2026-08-12
Date received: 2025-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K253846.pdf

Official FDA record: K253846

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.