FDA 510(k)

EsophaCap 可吞咽性细胞回收装置（从Cell-Mata更名）

K号: K203450 · 2021-05-04

决定日期2021-05-04

产品代码EOX

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决定实质等同

器械摘要

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.

常见问题

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.

官方来源

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EsophaCap 可吞咽性细胞回收装置（从Cell-Mata更名）

器械摘要

常见问题

相关临床试验

相关器械（代码：EOX）

官方来源