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FDA 510(k)

Ambu® aScope™ Gastro, Ambu® aBox™2

K-Number: K212382 · 2022-02-03

ApplicantAmbu A/S
Decision Date2022-02-03
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ambu® aScope™ Gastro, Ambu® aBox™2 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 2022-02-03 under 510(k) number K212382. 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® aBox™2?

Ambu® aScope™ Gastro, Ambu® aBox™2 is a medical device that received FDA 510(k) clearance on 2022-02-03. The listed applicant is Ambu A/S. The 510(k) number is K212382.

When did Ambu® aScope™ Gastro, Ambu® aBox™2 receive FDA 510(k) clearance?

Ambu® aScope™ Gastro, Ambu® aBox™2 received FDA 510(k) clearance on 2022-02-03, under 510(k) number K212382.

Who is the listed applicant for Ambu® aScope™ Gastro, Ambu® aBox™2?

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® aBox™2?

The FDA product code for Ambu® aScope™ Gastro, Ambu® aBox™2 is FDS.

Other records listing Ambu A/S as applicant

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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.

K253702Intuitive 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 CorporationK251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)Pentax of America, Inc.K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, Inc.

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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