Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02) +2 more— 510(k) K253846
Substantially EquivalentHangzhou 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.
Summary
Hangzhou Ruidi Biotechnology's submission lists a Steep Pulse Ablation Instrument (SPA-C02), described as including a disposable sterile probe, plus a Disposable Sterile Steep Pulse Probe (NPA-DJ01) and a probe connection line (NPA-LX-02). The product code is OAB, low energy direct current thermal ablation systems.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Ruidi filed from Hangzhou, China. The substantially equivalent decision came 253 calendar days after receipt (December 2, 2025 to August 12, 2026).
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
- Product code OAB
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code OAB
view allAdverse events under product code OAB
product code OAB- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . 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.