FDA 510(k)

Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)

K-Number: K250269 · 2025-06-11

Decision Date2025-06-11

Product CodeFAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) is a medical device manufactured by Ambu A/S. It received FDA 510(k) clearance on 2025-06-11 under approval number K250269. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)?

Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) is a medical device that received FDA 510(k) clearance on 2025-06-11. It is manufactured by Ambu A/S. The 510(k) number is K250269.

When was Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) approved by the FDA?

Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) received FDA 510(k) clearance on 2025-06-11, under approval number K250269.

What company makes Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)?

Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) is manufactured by Ambu A/S.

What is the FDA product code for Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)?

The FDA product code for Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) is FAJ.

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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: FAJ)

K160766Ambu USR, Ambu MAmbu A/S K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree CystoscopeSolace Therapeutics, Inc. K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. K171500Uro-V CystoscopeUroviu Corporation K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.

Official Source

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