510(k) K220606

Device: Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
Applicant: Ambu A/S
510(k) number: K220606
Product code: EOQ
Decision: Substantially Equivalent (SESE)
Decision date: 2022-07-25
Date received: 2022-03-02
Regulation: 874.4680
Classification name: Bronchoscope (Flexible Or Rigid)
Medical specialty: Ear, Nose, Throat
Review panel: Ear, Nose, Throat
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Gurpreet Kaur Rehal
Address: Baltorpbakken 13 Ballerup DK 2750 2750

FDA Registration Numbers

3024021261
1221485
9681147
3006984716
3006621103
3035710892
1000484830
3007867778
1526611
3015316279
2243757
3014605202
2244478
3042225166
1833700
3007305485
1000121056
3011416394
3033509898
8010047
1220850
3011050570
3016096100
3010202439
2032112
3030504644
3018094310
2011171
8030673
3014246639
1319639
3003678543
3004962788
3006161756
3009171251
3001675293
3025349506
3010398867
3017367014
3023460764
8010273
9611102
1721686
3008729892
9710524
3004040397
3004083736
3026787544
3010220595
3007084728
3004837686
3003761012
2029015
3010273872
3040391040
3013528571
3015970743
2124215
1221826
3029929134
3017425975
3008386005
3004065885
3013283620
3004111573
3033536312
3009039068
3015142721
1037905
3021325287
3042172882
3017140456
2020550
3002808148
2242464
9610595
9613846
3043226252
3027205723
3010383847

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EOQ

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K260565	SmartClip Delivery Catheter (ADR-1715)	Elucent Medical	2026-05-14
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K260420	LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)	MacroLux Medical Technology Co., Ltd.	2026-04-08
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K252045	Ion Endoluminal System (IF1000)	Intuitive Surgical, Inc.	2025-09-23
K251894	Himaging Bronchscope System	Himaging Technology (Shanghai) Co., Ltd.	2025-09-23
K252528	Ion Endoluminal System (IF1000)	Intuitive Surgical, Inc.	2025-09-05
K251752	Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)	Shanghai AnQing Medical Instrument Co., Ltd.	2025-08-27
K251823	UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)	Zhejiang UE Medical Corp.	2025-08-11
K250232	Vathin® Video Bronchoscope System	Hunan Vathin Medical Instrument Co., Ltd.	2025-07-25
K250862	EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)	Olympus Medical Systems Corp.	2025-06-23
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K250118	Disposable Balloon Catheter B5-2C	Olympus Medical Systems Corporation	2025-06-04
K250957	Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)	Olympus Medical Systems Corporation	2025-05-30