FDA 510(k)

Resitu Slider 09 (RESL09)

Номер K: K252183 · 2025-09-24

Дата решения2025-09-24

Код продуктаKNW

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Resitu Slider 09 (RESL09) is the device name listed in this FDA 510(k) record. The listed applicant is Resitu Medical AB. It received FDA 510(k) clearance on 2025-09-24 under 510(k) number K252183. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Resitu Slider 09 (RESL09)?

Resitu Slider 09 (RESL09) is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is Resitu Medical AB. The 510(k) number is K252183.

When did Resitu Slider 09 (RESL09) receive FDA 510(k) clearance?

Resitu Slider 09 (RESL09) received FDA 510(k) clearance on 2025-09-24, under 510(k) number K252183.

Who is the listed applicant for Resitu Slider 09 (RESL09)?

The FDA 510(k) record lists Resitu Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resitu Slider 09 (RESL09)?

The FDA product code for Resitu Slider 09 (RESL09) is KNW.

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: KNW)

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLC K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.

Официальный источник

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