FDA 510(k)

BeneHold™ Surgical Incise Drape with CHG antimicrobial II

Номер K: K230645 · 2023-10-25

Дата решения2023-10-25

Код продуктаKKX

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

BeneHold™ Surgical Incise Drape with CHG antimicrobial II is the device name listed in this FDA 510(k) record. The listed applicant is Avery Dennison Medical , Ltd.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K230645. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

BeneHold™ Surgical Incise Drape with CHG antimicrobial II is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Avery Dennison Medical , Ltd.. The 510(k) number is K230645.

When did BeneHold™ Surgical Incise Drape with CHG antimicrobial II receive FDA 510(k) clearance?

BeneHold™ Surgical Incise Drape with CHG antimicrobial II received FDA 510(k) clearance on 2023-10-25, under 510(k) number K230645.

Who is the listed applicant for BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

The FDA 510(k) record lists Avery Dennison Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

The FDA product code for BeneHold™ Surgical Incise Drape with CHG antimicrobial II is KKX.

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: KKX)

K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba K200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.

Официальный источник

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