FDA 510(k)

Pledgeted COR-SUTURE QUICK LOAD

Номер K: K160529 · 2016-09-15

Дата решения2016-09-15

Код продуктаGAW

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Pledgeted COR-SUTURE QUICK LOAD is the device name listed in this FDA 510(k) record. The listed applicant is Lsi Soultions. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K160529. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Pledgeted COR-SUTURE QUICK LOAD?

Pledgeted COR-SUTURE QUICK LOAD is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Lsi Soultions. The 510(k) number is K160529.

When did Pledgeted COR-SUTURE QUICK LOAD receive FDA 510(k) clearance?

Pledgeted COR-SUTURE QUICK LOAD received FDA 510(k) clearance on 2016-09-15, under 510(k) number K160529.

Who is the listed applicant for Pledgeted COR-SUTURE QUICK LOAD?

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

What is the FDA product code for Pledgeted COR-SUTURE QUICK LOAD?

The FDA product code for Pledgeted COR-SUTURE QUICK LOAD is GAW.

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: GAW)

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris Medical K230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsi K192953APTOS Нити – Полипропиленовые Хирургические ШвыAptos, LLC

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