FDA 510(k)

Ambu® aScope Gastro, Ambu® aBox2

K-Number: K212382 · 2022-02-03

Decision Date2022-02-03

Product CodeFDS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Ambu® aScope Gastro, Ambu® aBox2 is a medical device manufactured by Ambu A/S. It received FDA 510(k) clearance on 2022-02-03 under approval 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® aBox2?

Ambu® aScope Gastro, Ambu® aBox2 is a medical device that received FDA 510(k) clearance on 2022-02-03. It is manufactured by Ambu A/S. The 510(k) number is K212382.

When was Ambu® aScope Gastro, Ambu® aBox2 approved by the FDA?

Ambu® aScope Gastro, Ambu® aBox2 received FDA 510(k) clearance on 2022-02-03, under approval number K212382.

What company makes Ambu® aScope Gastro, Ambu® aBox2?

Ambu® aScope Gastro, Ambu® aBox2 is manufactured by Ambu A/S.

What is the FDA product code for Ambu® aScope Gastro, Ambu® aBox2?

The FDA product code for Ambu® aScope Gastro, Ambu® aBox2 is FDS.

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: FDS)

K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. K180292PENTAX Video Upper G.I. Scope EG34-i10Pentax Medical of America, Inc. K180341FUJIFILM 600 Series Endoscope EG-600WR v2Fujifilm Corporation K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation K180911Visura Technologies TEECAD SystemVisura Technologies, LLC

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.