Cleared Special

SCOPE BUDDY PLUS Endoscope Flushing Aid

K213833 · Medivators, Inc. · General Hospital

Jan 2022

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K213833 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 January 14, 2022, 36 days after receiving the submission on December 9, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K213833 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2021
Decision Date	January 14, 2022
Days to Decision	36 days
Submission Type	Special
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).