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FDA 510(k)

EndoSign® Cell collection device (ES-CYT-102)

K-Number: K233142 · 2024-01-19

ApplicantCyted Limited
Decision Date2024-01-19
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EndoSign® Cell collection device (ES-CYT-102) is the device name listed in this FDA 510(k) record. The listed applicant is Cyted Limited. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K233142. 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 EndoSign® Cell collection device (ES-CYT-102)?

EndoSign® Cell collection device (ES-CYT-102) is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Cyted Limited. The 510(k) number is K233142.

When did EndoSign® Cell collection device (ES-CYT-102) receive FDA 510(k) clearance?

EndoSign® Cell collection device (ES-CYT-102) received FDA 510(k) clearance on 2024-01-19, under 510(k) number K233142.

Who is the listed applicant for EndoSign® Cell collection device (ES-CYT-102)?

The FDA 510(k) record lists Cyted Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoSign® Cell collection device (ES-CYT-102)?

The FDA product code for EndoSign® Cell collection device (ES-CYT-102) 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.

NCT06803927Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device SamplesRECRUITING

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.

K230339EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.K222366EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLCK210137EsoCheck 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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