FDA 510(k)

SCOPE BUDDY PLUS Endoscope Flushing Aid

K-Number: K213833 · 2022-01-14

Decision Date2022-01-14

Product CodeFEB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SCOPE BUDDY PLUS Endoscope Flushing Aid is a medical device manufactured by Medivators, Inc.. It received FDA 510(k) clearance on 2022-01-14 under approval number K213833. 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 BUDDY PLUS Endoscope Flushing Aid?

SCOPE BUDDY PLUS Endoscope Flushing Aid is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Medivators, Inc.. The 510(k) number is K213833.

When was SCOPE BUDDY PLUS Endoscope Flushing Aid approved by the FDA?

SCOPE BUDDY PLUS Endoscope Flushing Aid received FDA 510(k) clearance on 2022-01-14, under approval number K213833.

What company makes SCOPE BUDDY PLUS Endoscope Flushing Aid?

SCOPE BUDDY PLUS Endoscope Flushing Aid is manufactured by Medivators, Inc..

What is the FDA product code for SCOPE BUDDY PLUS Endoscope Flushing Aid?

The FDA product code for SCOPE BUDDY PLUS Endoscope Flushing Aid is FEB.

Other Devices by Medivators, Inc.

K162128Scope Buddy Plus Endoscope Flushing Aid K160846AmplifEYE K152394Rapicide PA High-Level Disinfectant Test Strips K172677Advantage Plus Pass-Thru K223040Endo SmartCap

Related Devices (Code: FEB)

K162128Scope Buddy Plus Endoscope Flushing AidMedivators, Inc. K152189EVOTECH ECRAdvanced Sterilization Products (Asp) K172677Advantage Plus Pass-ThruMedivators, Inc. K162120Scope-Assist Flushing SinkCustom Ultrasonics, Inc. K181865Acu-sInQ Complete Endoscope Cleaning Aid SystemSTERIS Corporation K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp.

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.