FDA 510(k)

Scope-Assist Flushing Sink

K-Number: K162120 · 2017-04-28

Decision Date2017-04-28

Product CodeFEB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Scope-Assist Flushing Sink is a medical device manufactured by Custom Ultrasonics, Inc.. It received FDA 510(k) clearance on 2017-04-28 under approval 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. It is manufactured by Custom Ultrasonics, Inc.. The 510(k) number is K162120.

When was Scope-Assist Flushing Sink approved by the FDA?

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

What company makes Scope-Assist Flushing Sink?

Scope-Assist Flushing Sink is manufactured by Custom Ultrasonics, Inc..

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

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

Other Devices by Custom Ultrasonics, Inc.

K173590System 83 Plus Washer/Disinfector

Related Devices (Code: FEB)

K162128Scope Buddy Plus Endoscope Flushing AidMedivators, Inc. K152189EVOTECH ECRAdvanced Sterilization Products (Asp) K172677Advantage Plus Pass-ThruMedivators, Inc. K181865Acu-sInQ Complete Endoscope Cleaning Aid SystemSTERIS Corporation K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. K181472AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorAdvanced Sterilization Products (Asp)

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.