FDA 510(k)

Instinct Plus Endoscopic Clipping Device

Номер K: K192697 · 2020-03-05

Дата решения2020-03-05

Код продуктаPKL

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Instinct Plus Endoscopic Clipping Device is the device name listed in this FDA 510(k) record. The listed applicant is Cook Endoscopy. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K192697. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Instinct Plus Endoscopic Clipping Device?

Instinct Plus Endoscopic Clipping Device is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is Cook Endoscopy. The 510(k) number is K192697.

When did Instinct Plus Endoscopic Clipping Device receive FDA 510(k) clearance?

Instinct Plus Endoscopic Clipping Device received FDA 510(k) clearance on 2020-03-05, under 510(k) number K192697.

Who is the listed applicant for Instinct Plus Endoscopic Clipping Device?

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

What is the FDA product code for Instinct Plus Endoscopic Clipping Device?

The FDA product code for Instinct Plus Endoscopic Clipping Device is PKL.

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: PKL)

K253481colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)Ovesco Endoscopy AG K254069Hemoclip (511 series, 543 series)Hangzhou AGS MedTech Co., Ltd.K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)Olympus Medical Systems Corp.K252270HemoclipHangzhou AGS MedTech Co., Ltd.K253734Taurus ClipTaurus Endoscopy K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG

Официальный источник

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