510(k) clearance

Disposable Distal Attachment D-201-13404

FDA 510(k) source

510(k) number

K260856

Applicant

Olympus Medical Systems Corporation

Decision date

Aug 27, 2026

Date received

Mar 16, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

FDS

Device type

Gastroscope And Accessories, Flexible/Rigid

Device class

Class II

Regulation

21 CFR 876.1500

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Hachioji-Shi, JP