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FDA 510(k), K203450, EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
FDA 510(k), K203450, EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
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$149.00 USD
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510(K) Number: K203450
Device Name: EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
Manufacturer: Martin von Dyck
Device Classification Name: Esophagoscope (Flexible Or Rigid)
Regulation Number: EOX
Classification Product Code: 11/23/2020
Date Received: 05/04/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
Manufacturer: Martin von Dyck
Device Classification Name: Esophagoscope (Flexible Or Rigid)
Regulation Number: EOX
Classification Product Code: 11/23/2020
Date Received: 05/04/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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