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FDA 510(k)

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor

K-Number: K181292 · 2018-11-15

ApplicantCogentix Medical, Inc.
Decision Date2018-11-15
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor is the device name listed in this FDA 510(k) record. The listed applicant is Cogentix Medical, Inc.. It received FDA 510(k) clearance on 2018-11-15 under 510(k) number K181292. 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 PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor?

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Cogentix Medical, Inc.. The 510(k) number is K181292.

When did PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor receive FDA 510(k) clearance?

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor received FDA 510(k) clearance on 2018-11-15, under 510(k) number K181292.

Who is the listed applicant for PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor?

The FDA 510(k) record lists Cogentix Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor?

The FDA product code for PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor is EOX.

Other records listing Cogentix Medical, Inc. 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.

K253905PrimeSight UltraView System

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

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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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