Cleared Traditional

Sharpsite AC Rigid Endsocope

K173855 · Medtronic Xomed, Inc. · Ear, Nose, Throat

Apr 2018

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K173855 is an FDA 510(k) clearance for the Sharpsite AC Rigid Endsocope, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on April 20, 2018, 121 days after receiving the submission on December 20, 2017. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K173855 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2017
Decision Date	April 20, 2018
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOB — Nasopharyngoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4760
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).