DeviceClearance

Ambu® aScope Gastro; Ambu® aScope Gastro Large— 510(k) K261400

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K261400 for Ambu® aScope Gastro; Ambu® aScope Gastro Large, Substantially Equivalent on 2026-09-16. Applicant: Ambu A/S. Device class: 2.

Summary

Ambu A/S submitted two scopes, the aScope Gastro and the aScope Gastro Large, under product code FDS (Gastroscope And Accessories, Flexible/Rigid). The record doesn't say how the two differ.

Class II, 21 CFR 876.1500. Gastroenterology, Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.

Ambu filed from Ballerup, Denmark. The decision came 140 calendar days after receipt (April 29 to September 16, 2026).

Clearance details

Applicant
Ambu A/S
Product code
Product code FDS
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
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 FDS

product code FDS
Death
37
Injury
863
Malfunction
56,442
Other
1
Total
57,343

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.