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FDA 510(k)

CMOS Video Esophagoscope SSU

K-Number: K192523 · 2020-01-24

ApplicantKarl Storz SE & CO. KG
Decision Date2020-01-24
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CMOS Video Esophagoscope SSU is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2020-01-24 under 510(k) number K192523. 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 CMOS Video Esophagoscope SSU?

CMOS Video Esophagoscope SSU is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K192523.

When did CMOS Video Esophagoscope SSU receive FDA 510(k) clearance?

CMOS Video Esophagoscope SSU received FDA 510(k) clearance on 2020-01-24, under 510(k) number K192523.

Who is the listed applicant for CMOS Video Esophagoscope SSU?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMOS Video Esophagoscope SSU?

The FDA product code for CMOS Video Esophagoscope SSU is EOX.

Other records listing Karl Storz SE & CO. KG as applicant

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.

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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.K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLCK210137EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.

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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