FDA 510(k)

Ambu® aScope Colon; Ambu® aBox 2

K-Number: K230332 · 2023-09-15

Decision Date2023-09-15

Product CodeFDF

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Ambu® aScope Colon; Ambu® aBox 2 is a medical device manufactured by Ambu A/S. It received FDA 510(k) clearance on 2023-09-15 under approval number K230332. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ambu® aScope Colon; Ambu® aBox 2?

Ambu® aScope Colon; Ambu® aBox 2 is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by Ambu A/S. The 510(k) number is K230332.

When was Ambu® aScope Colon; Ambu® aBox 2 approved by the FDA?

Ambu® aScope Colon; Ambu® aBox 2 received FDA 510(k) clearance on 2023-09-15, under approval number K230332.

What company makes Ambu® aScope Colon; Ambu® aBox 2?

Ambu® aScope Colon; Ambu® aBox 2 is manufactured by Ambu A/S.

What is the FDA product code for Ambu® aScope Colon; Ambu® aBox 2?

The FDA product code for Ambu® aScope Colon; Ambu® aBox 2 is FDF.

Other Devices by Ambu A/S

K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator K160766Ambu USR, Ambu M K181286Ambu aScope RLS Slim K173727Ambu 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 K190972Ambu aScope 4 RhinoLaryngo Intervention

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Related Devices (Code: FDF)

K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. K160015Pure VuMotus GI Medical Technologies , Ltd. K161355invendoscopy E200 SystemInvendo Medical GmbH K161791Aer-O-Scope Colonoscope SystemGi View , Ltd. K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, 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.