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FDA 510(k)

Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large

K-Number: K261400 · 2026-09-16

ApplicantAmbu A/S
Decision Date2026-09-16
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large is the device name listed in this FDA 510(k) record. The listed applicant is Ambu A/S. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K261400. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large?

Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Ambu A/S. The 510(k) number is K261400.

When did Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large receive FDA 510(k) clearance?

Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261400.

Who is the listed applicant for Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large?

The FDA 510(k) record lists Ambu A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large?

The FDA product code for Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large is FDS.

Other records listing Ambu A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetK260578Ambu® 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)K251583Ambu® Virobac II® Exhalation FilterK250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2K240848Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance

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Related Devices (Code: FDS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260856Disposable Distal Attachment D-201-13404Olympus Medical Systems CorporationK260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems CorporationK253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm CorporationK253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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