510(k) clearance

Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set

FDA 510(k) source

510(k) number

K260309

Applicant

Ambu A/S

Decision date

Sep 16, 2026

Date received

Jan 30, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

EOQ

Device type

Bronchoscope (Flexible Or Rigid)

Device class

Class II

Regulation

21 CFR 874.4680

Advisory committee

Ear, Nose, Throat

Statement or summary

Summary

Third party

N

Location

Ballerup, DK