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FDA 510(k)

Scope Buddy Plus Endoscope Flushing Aid

K-Number: K162128 · 2016-12-21

ApplicantMedivators, Inc.
Decision Date2016-12-21
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Scope Buddy Plus Endoscope Flushing Aid is the device name listed in this FDA 510(k) record. The listed applicant is Medivators, Inc.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K162128. 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 2016-12-21. The listed applicant is Medivators, Inc.. The 510(k) number is K162128.

When did Scope Buddy Plus Endoscope Flushing Aid receive FDA 510(k) clearance?

Scope Buddy Plus Endoscope Flushing Aid received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162128.

Who is the listed applicant for Scope Buddy Plus Endoscope Flushing Aid?

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

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 records listing Medivators, 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.

K231418ENDOGATOR™ Hybrid Irrigation TubingK223040Endo SmartCapK213833SCOPE BUDDY PLUS Endoscope Flushing AidK172677Advantage Plus Pass-ThruK160846AmplifEYEK152394Rapicide PA High-Level Disinfectant Test Strips

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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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