FDA 510(k)

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)

Номер K: K203450 · 2021-05-04

Дата решения2021-05-04

Код продуктаEOX

Консультативный комитетEN

РешениеSubstantially Equivalent

Описание устройства

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) is the device name listed in this FDA 510(k) record. The listed applicant is Capnostics, LLC. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K203450. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)?

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Capnostics, LLC. The 510(k) number is K203450.

When did EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) receive FDA 510(k) clearance?

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) received FDA 510(k) clearance on 2021-05-04, under 510(k) number K203450.

Who is the listed applicant for EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)?

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

What is the FDA product code for EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)?

The FDA product code for EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) is EOX.

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: EOX)

K233142EndoSign® Cell collection device (ES-CYT-102)Cyted Limited K230339EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.K222366EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K210137EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K192523CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG

Официальный источник

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