FDA 510(k)

RF Cannula

Номер K: K241367 · 2025-01-23

ЗаявительShanghai Samedical & Plastic Instruments Co., Ltd.

Дата решения2025-01-23

Код продуктаGXI

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

RF Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Samedical & Plastic Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-01-23 under 510(k) number K241367. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the RF Cannula?

RF Cannula is a medical device that received FDA 510(k) clearance on 2025-01-23. The listed applicant is Shanghai Samedical & Plastic Instruments Co., Ltd.. The 510(k) number is K241367.

When did RF Cannula receive FDA 510(k) clearance?

RF Cannula received FDA 510(k) clearance on 2025-01-23, under 510(k) number K241367.

Who is the listed applicant for RF Cannula?

The FDA 510(k) record lists Shanghai Samedical & Plastic Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RF Cannula?

The FDA product code for RF Cannula is GXI.

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: GXI)

K253907Disposable Radiofrequency CannulaABBOTT MEDICAL K251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICAL K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker Instruments K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.

Официальный источник

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