Cleared Traditional

Ambu aScope RLS Slim

K181286 · Ambu A/S · Ear, Nose, Throat

Nov 2018

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K181286 is an FDA 510(k) clearance for the Ambu aScope RLS Slim, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on November 30, 2018, 198 days after receiving the submission on May 16, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K181286 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2018
Decision Date	November 30, 2018
Days to Decision	198 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).