FDA 510(k)

InstruSafe Instrument Protection System

Номер K: K210836 · 2021-11-30

Дата решения2021-11-30

Код продуктаKCT

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

InstruSafe Instrument Protection System is the device name listed in this FDA 510(k) record. The listed applicant is Summitt Medical, LLC. It received FDA 510(k) clearance on 2021-11-30 under 510(k) number K210836. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the InstruSafe Instrument Protection System?

InstruSafe Instrument Protection System is a medical device that received FDA 510(k) clearance on 2021-11-30. The listed applicant is Summitt Medical, LLC. The 510(k) number is K210836.

When did InstruSafe Instrument Protection System receive FDA 510(k) clearance?

InstruSafe Instrument Protection System received FDA 510(k) clearance on 2021-11-30, under 510(k) number K210836.

Who is the listed applicant for InstruSafe Instrument Protection System?

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

What is the FDA product code for InstruSafe Instrument Protection System?

The FDA product code for InstruSafe Instrument Protection System is KCT.

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: KCT)

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Официальный источник

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