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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 a medical device manufactured by Capnostics, LLC. It received FDA 510(k) clearance on 2021-05-04 under approval 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. It is manufactured by Capnostics, LLC. The 510(k) number is K203450.

When was EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) approved by the FDA?

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

What company makes EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)?

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) is manufactured by Capnostics, LLC.

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.

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 40573269 Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union. Pharmaceuticals (Basel, Switzerland) (2025)

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Official Source

View on FDA Database →

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

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