Cleared Traditional

Scope Buddy Plus Endoscope Flushing Aid

K162128 · Medivators, Inc. · General Hospital

Dec 2016

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K162128 is an FDA 510(k) clearance for the Scope Buddy Plus Endoscope Flushing Aid, a Accessories, Cleaning, For Endoscope (Class II — Special Controls, product code FEB), submitted by Medivators, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 21, 2016, 142 days after receiving the submission on August 1, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K162128 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2016
Decision Date	December 21, 2016
Days to Decision	142 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FEB — Accessories, Cleaning, For Endoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).