FDA 510(k)

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

Número K: K203450 · 2021-05-04

Data da decisão2021-05-04

Código do produtoEOX

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: 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

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.