Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2 +3 more— 510(k) K173727

Clearance details

Device name as filed

Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor

Applicant

Ambu A/S

Product code

Code EOQ

Device class

Class 2

Regulation

21 CFR 874.4680

Advisory panel

Ear, Nose, Throat

Date received

2017-12-05

Decision date

2018-03-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ballerup, DK

• K254026 — 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U) +3 more2026-09-02
• K260382 — MONARCH Platform (MON-000008)2026-07-25
• K254037 — LungFlow Airway Catheter2026-07-10
• K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T2026-06-16
• K260565 — SmartClip Delivery Catheter (ADR-1715)2026-05-14

• K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)2026-07-14
• K251583 — Ambu® Virobac II® Exhalation Filter2026-04-30
• K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)2025-06-11
• K240849 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 22024-10-16
• K240848 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance2024-10-10

Death

135

Injury

2,863

Malfunction

21,662

Total

24,660

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 →