Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02) +2 more— 510(k) K253846

Name: FDA 510(k) clearance K253846
Creator: U.S. Food and Drug Administration
Published: 2026-08-12

Substantially Equivalent

Hangzhou Ruidi Biotechnology , Ltd.

FDA 510(k) clearance K253846 for Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02) +2 more, Substantially Equivalent on 2026-08-12. Applicant: Hangzhou Ruidi Biotechnology , Ltd.. Device class: 2.

Clearance details

Device name as filed: 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.
Product code: Code OAB
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2025-12-02
Decision date: 2026-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OAB

product code OAB

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.