Cleared Traditional

VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

K243380 · Olympus Medical Systems Corporation · Ear, Nose, Throat

Mar 2025

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K243380 is an FDA 510(k) clearance for the VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500), a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Olympus Medical Systems Corporation (Hachioji-Shi, JP). The FDA issued a Cleared decision on March 3, 2025, 124 days after receiving the submission on October 30, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K243380 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 30, 2024
Decision Date	March 03, 2025
Days to Decision	124 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).