EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)— 510(k) K203450

Substantially Equivalent

Capnostics, LLC

FDA 510(k) clearance K203450 for EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata), Substantially Equivalent on 2021-05-04. Applicant: Capnostics, LLC.

Clearance details

Applicant: Capnostics, LLC
Product code: Code EOX
Advisory panel: Ear, Nose, Throat
Date received: 2020-11-23
Decision date: 2021-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, NC, US

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