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FDA 510(k)

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

K-Number: K203450 · 2021-05-04

ApplicantCapnostics, LLC
Decision Date2021-05-04
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05028725Novel Strategy for Early Detection of Esophageal Squamous Cell CarcinomaRECRUITING

Related Devices (Code: EOX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233142EndoSign® Cell collection device (ES-CYT-102)Cyted LimitedK230339EsoCheck 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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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