Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2— 510(k) K233630

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K233630 for Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2, Substantially Equivalent on 2024-06-24. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2023-11-13
Decision date: 2024-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.