Ambu A/S

Code	Device name	Class	Specialty	Clearances	Most recent
EOQ	Bronchoscope (Flexible Or Rigid)	Class II	Ear, Nose, Throat	7	2024-01-04
FAJ	Cystoscope And Accessories, Flexible/Rigid	Class II	Gastroenterology, Urology	4	2025-06-11
FGB	—	—	—	2	2024-08-16
FDS	—	—	—	2	2024-04-05
GXY	Electrode, Cutaneous	Class II	Neurology	1	2026-07-14
CAH	—	—	—	1	2026-04-30
FDT	Duodenoscope And Accessories, Flexible/Rigid	Class II	Gastroenterology, Urology	1	2024-04-16
FDF	—	—	—	1	2023-09-15
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Class II	Anesthesiology	1	2021-05-03

Date	K-number	Device	Code	Class	Specialty
2026-07-14	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)	GXY	Class II	Neurology
2026-04-30	K251583	Ambu® Virobac II® Exhalation Filter	CAH	—	—
2025-06-11	K250269	Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)	FAJ	Class II	Gastroenterology, Urology
2024-10-16	K240849	Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2	FAJ	Class II	Gastroenterology, Urology
2024-10-10	K240848	Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance	FAJ	Class II	Gastroenterology, Urology
2024-08-16	K242108	Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance	FGB	—	—
2024-06-24	K233630	Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2	FGB	—	—
2024-04-16	K233886	Ambu® aScope Duodeno 2, Ambu® aBox 2	FDT	Class II	Gastroenterology, Urology
2024-04-05	K232919	Ambu® aScope Gastro Large; Ambu® aBox 2	FDS	—	—
2024-01-04	K233671	Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance	EOQ	Class II	Ear, Nose, Throat
2023-09-20	K232582	Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set	EOQ	Class II	Ear, Nose, Throat
2023-09-15	K230332	Ambu® aScope Colon; Ambu® aBox 2	FDF	—	—
2023-08-10	K230428	Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2	EOQ	Class II	Ear, Nose, Throat
2023-06-01	K223299	Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance	EOQ	Class II	Ear, Nose, Throat
2023-01-12	K223782	Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set	EOQ	Class II	Ear, Nose, Throat
2022-07-25	K220606	Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2	EOQ	Class II	Ear, Nose, Throat
2022-02-03	K212382	Ambu® aScope Gastro, Ambu® aBox2	FDS	—	—
2021-06-17	K210883	aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8	EOQ	Class II	Ear, Nose, Throat
2021-05-03	K203749	Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable	CBI	Class II	Anesthesiology
2020-04-02	K193095	Ambu aScope 4 Cysto	FAJ	Class II	Gastroenterology, Urology

Clearance cadence by quarter

Product codes worked

All 510(k) clearances (20)