Cleared Traditional

Advantage Plus Pass-Thru

K172677 · Medivators, Inc. · General Hospital

Dec 2017

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K172677 is an FDA 510(k) clearance for the Advantage Plus Pass-Thru, 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 19, 2017, 105 days after receiving the submission on September 5, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K172677 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 2017
Decision Date	December 19, 2017
Days to Decision	105 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).