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)— 510(k) K260578
Substantially EquivalentAmbu A/S
FDA 510(k) clearance K260578 for 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), Substantially Equivalent on 2026-07-14. Applicant: Ambu A/S. Device class: 2.
Summary
Ambu's clearance covers the Neuroline Cup MRI/CT, the Neuroline Cup MRI/CT-set, and the Neuroline Cup MRI/CT-mini set, each listed in several 72704-series models. They're filed under GXY, cutaneous electrodes.
Class II, 21 CFR 882.1320. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Ambu filed from Ballerup, Denmark. The decision came 144 calendar days after receipt (February 20 to July 14, 2026).
Clearance details
- Applicant
- Ambu A/S
- Product code
- Product code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ballerup, DK
Recent devices under product code GXY
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- K262654 — Dexus Prosthetic System (MSL2, MSR2)
- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- K261522 — BioWave BioWraps
- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
More clearances from Ambu A/S
view all- K260309 — 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
- K261400 — Ambu® aScope Gastro; Ambu® aScope Gastro Large
- K251583 — Ambu® Virobac II® Exhalation Filter
- K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)
- K240849 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2
Data sourced from openFDA. This site is unofficial and independent of the FDA.