510(k) clearance

Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large

FDA 510(k) source

510(k) number

K261400

Applicant

Ambu A/S

Decision date

Sep 16, 2026

Date received

Apr 29, 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

Ballerup, DK