FDA 510(k)

DuraFuse Clip and Applier System

Номер K: K213813 · 2022-07-22

Дата решения2022-07-22

Код продуктаFZP

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

DuraFuse Clip and Applier System is the device name listed in this FDA 510(k) record. The listed applicant is Neuramedica, Inc.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K213813. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the DuraFuse Clip and Applier System?

DuraFuse Clip and Applier System is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Neuramedica, Inc.. The 510(k) number is K213813.

When did DuraFuse Clip and Applier System receive FDA 510(k) clearance?

DuraFuse Clip and Applier System received FDA 510(k) clearance on 2022-07-22, under 510(k) number K213813.

Who is the listed applicant for DuraFuse Clip and Applier System?

The FDA 510(k) record lists Neuramedica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DuraFuse Clip and Applier System?

The FDA product code for DuraFuse Clip and Applier System is FZP.

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: FZP)

K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation K253781InnoClip Clip ApplierTaiwan Surgical Corporation K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical

Официальный источник

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