FDA 510(k)

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B

Номер K: K200769 · 2021-01-06

ЗаявительWilson Instruments (Sha) Co., Ltd.

Дата решения2021-01-06

Код продуктаODC

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B is the device name listed in this FDA 510(k) record. The listed applicant is Wilson Instruments (Sha) Co., Ltd.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K200769. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B?

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Wilson Instruments (Sha) Co., Ltd.. The 510(k) number is K200769.

When did Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B receive FDA 510(k) clearance?

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B received FDA 510(k) clearance on 2021-01-06, under 510(k) number K200769.

Who is the listed applicant for Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B?

The FDA 510(k) record lists Wilson Instruments (Sha) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B?

The FDA product code for Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B is ODC.

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: ODC)

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston Scientific K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation K250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

Официальный источник

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