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FDA 510(k)

Scope-Assist Flushing Sink

K-Number: K162120 · 2017-04-28

ApplicantCustom Ultrasonics, Inc.
Decision Date2017-04-28
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Scope-Assist Flushing Sink is the device name listed in this FDA 510(k) record. The listed applicant is Custom Ultrasonics, Inc.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K162120. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scope-Assist Flushing Sink?

Scope-Assist Flushing Sink is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Custom Ultrasonics, Inc.. The 510(k) number is K162120.

When did Scope-Assist Flushing Sink receive FDA 510(k) clearance?

Scope-Assist Flushing Sink received FDA 510(k) clearance on 2017-04-28, under 510(k) number K162120.

Who is the listed applicant for Scope-Assist Flushing Sink?

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

What is the FDA product code for Scope-Assist Flushing Sink?

The FDA product code for Scope-Assist Flushing Sink is FEB.

Other records listing Custom Ultrasonics, 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.

K173590System 83 Plus Washer/Disinfector

Related Devices (Code: FEB)

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.

K241168System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc.K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS CorporationK230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS CorporationK213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc.K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.K173590System 83 Plus Washer/DisinfectorCustom Ultrasonics, 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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