510(k) clearance

4K Camera Head OLYMPUS CH-S700-08-LB

FDA 510(k) source

510(k) number

K262079

Applicant

Olympus Medical Systems Corp.

Decision date

Sep 10, 2026

Date received

Jun 22, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

FET

Device type

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Device class

Class II

Regulation

21 CFR 876.1500

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Tokyo, JP