FDA 510(k)

SURGIPHOR Wound Irrigation System

Номер K: K202071 · 2020-10-23

Дата решения2020-10-23

Код продуктаFQH

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

SURGIPHOR Wound Irrigation System is the device name listed in this FDA 510(k) record. The listed applicant is Orthophor, LLC. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K202071. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the SURGIPHOR Wound Irrigation System?

SURGIPHOR Wound Irrigation System is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Orthophor, LLC. The 510(k) number is K202071.

When did SURGIPHOR Wound Irrigation System receive FDA 510(k) clearance?

SURGIPHOR Wound Irrigation System received FDA 510(k) clearance on 2020-10-23, under 510(k) number K202071.

Who is the listed applicant for SURGIPHOR Wound Irrigation System?

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

What is the FDA product code for SURGIPHOR Wound Irrigation System?

The FDA product code for SURGIPHOR Wound Irrigation System is FQH.

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: FQH)

K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH K220759Armis VeriCyn Wound WashArmis Biopharma, Inc.K220964VERSAJET Hydrosurgery System (III)Smith & Nephew Medical Limited K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd

Официальный источник

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