FDA 510(k)

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)

Номер K: K253846 · 2026-08-12

ЗаявительHangzhou Ruidi Biotechnology , Ltd.

Дата решения2026-08-12

Код продуктаOAB

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

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) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Ruidi Biotechnology , Ltd.. It received FDA 510(k) clearance on 2026-08-12 under 510(k) number K253846. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the 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)?

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) is a medical device that received FDA 510(k) clearance on 2026-08-12. The listed applicant is Hangzhou Ruidi Biotechnology , Ltd.. The 510(k) number is K253846.

When did 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) receive FDA 510(k) clearance?

Кто указан в качестве заявителя для Инструмента Аblation Steep Pulse (включаяSterile Disposable Steep Pulse Probe) (SPA-C02); Sterile Disposable Steep Pulse Probe (NPA-DJ01); Линия подключения探头 (NPA-LX-02)?

The FDA 510(k) record lists Hangzhou Ruidi Biotechnology , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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)?

The FDA product code for 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) is OAB.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: OAB)

K253826Aliya® EX Система; Aliya® EX Генератор; Aliya® Игла; Aliya® Электрод; INUMI™ Гибкая ИглаGalvanize Therapeutics, Inc.K253198NanoKnife Generator (H78720300351US0)Angiodynamics K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)AngioDynamics, Inc.K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC

Официальный источник

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