Cleared Traditional

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP

K221660 · Olympus Medical Systems Corp. · Ear, Nose, Throat

Dec 2022

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K221660 is an FDA 510(k) clearance for the RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Olympus Medical Systems Corp. (Hachiochi-Shi, JP). The FDA issued a Cleared decision on December 28, 2022, 203 days after receiving the submission on June 8, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K221660 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2022
Decision Date	December 28, 2022
Days to Decision	203 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).