Cleared Traditional

VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA

K242067 · Olympus Corporations of the Americas · General & Plastic Surgery

Apr 2025

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K242067 is an FDA 510(k) clearance for the VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA, a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II — Special Controls, product code FET), submitted by Olympus Corporations of the Americas (Westborough, US). The FDA issued a Cleared decision on April 2, 2025, 261 days after receiving the submission on July 15, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K242067 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2024
Decision Date	April 02, 2025
Days to Decision	261 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	FET — Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.