DeviceClearance

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— 510(k) K260309

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K260309 for 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, Substantially Equivalent on 2026-09-16. Applicant: Ambu A/S. Device class: 2.

Summary

Ambu A/S filed three aScope 5 Broncho versions under product code EOQ (Bronchoscope (Flexible Or Rigid)): 2.7/1.2, 4.2/2.2, and a 4.2/2.2 Sampler Set. The record doesn't explain the numbers in the names.

Class II, 21 CFR 874.4680. Ear, Nose, Throat is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.

Ambu filed from Ballerup, Denmark. The decision came 229 calendar days after receipt (January 30 to September 16, 2026).

Clearance details

Applicant
Ambu A/S
Product code
Product code EOQ
Device class
Class 2
Regulation
21 CFR 874.4680
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ballerup, DK
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EOQ

product code EOQ
Death
135
Injury
2,863
Malfunction
21,662
Total
24,660

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.