FDA 510(k)

Theia NPWT Foam Wound Dressing Kit

Номер K: K211277 · 2021-12-16

ЗаявительClear Choice Therapeutics, Inc.

Дата решения2021-12-16

Код продуктаOMP

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Theia NPWT Foam Wound Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Clear Choice Therapeutics, Inc.. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K211277. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Theia NPWT Foam Wound Dressing Kit?

Theia NPWT Foam Wound Dressing Kit is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Clear Choice Therapeutics, Inc.. The 510(k) number is K211277.

When did Theia NPWT Foam Wound Dressing Kit receive FDA 510(k) clearance?

Theia NPWT Foam Wound Dressing Kit received FDA 510(k) clearance on 2021-12-16, under 510(k) number K211277.

Who is the listed applicant for Theia NPWT Foam Wound Dressing Kit?

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

What is the FDA product code for Theia NPWT Foam Wound Dressing Kit?

The FDA product code for Theia NPWT Foam Wound Dressing Kit is OMP.

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: OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.

Официальный источник

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