510(k) K232919

Device: Ambu® aScope? Gastro Large; Ambu® aBox? 2
Applicant: Ambu A/S
510(k) number: K232919
Product code: FDS
Decision: Substantially Equivalent (SESE)
Decision date: 2024-04-05
Date received: 2023-09-19
Regulation: 876.1500
Classification name: Gastroscope And Accessories, Flexible/Rigid
Medical specialty: Gastroenterology, Urology
Review panel: Gastroenterology, Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Mette Andersen
Address: Baltorpbakken 13 Ballerup DK 2750 2750

FDA Registration Numbers

3009698186
3024021261
3014769442
1450997
3010141954
3018258446
2183744
3015223550
3013247477
3004040397
9617070
3008797804
3010220595
3004705634
3004837686
3014605202
3010703925
3010288205
1000163068
3015194986
3004644065
3015746529
3002807310
9611112
3003790304
9610691
3015525240
1221826
3005099803
3015131155
9610877
3042225166
3008386005
3021246306
3004111573
3010390468
3011816755
3011416394
3008627763
3010707607
9614641
3011050570
8010047
3042172882
3003775006
3003782610
3010202439
9610617
3017140456
9611680
1649518
3012843412
3002808148
2020550
3014342096
3010188783
3013440400
3012494290
1528319
3013944123
3015451828
3006161756
3009171251
9610595
3015136743
3043226252
3015807001
3021691063
3013023255

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FDS

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K253568	Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR	Fujifilm Corporation	2026-02-06
K251256	PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)	Pentax of America, Inc.	2025-12-16
K251041	GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100	Actuated Medical, Inc.	2025-10-31
K251708	EvoEndo Single-Use Endoscopy System	EvoEndo, Inc.	2025-10-10
K243388	Disposable Distal Cap	Micro-Tech (Nanjing) Co., Ltd.	2025-06-27
K250900	EvoEndo Single-Use Endoscopy System	EvoEndo, Inc.	2025-06-16
K243512	FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP	Fujifilm Corporation	2025-06-10
K242635	Endoscopic Distal Attachment (AF-D series)	Alton (Shanghai) Medical Instruments Co., Ltd.	2025-05-30
K250296	Disposable Distal Attachment D-201 Series	Olympus Medical Systems Corp.	2025-05-01
K241213	PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)	Pentax of America, Inc.	2024-12-06
K242779	Hood (DH-083ST)	Fujifilm Corporation	2024-10-11
K240142	FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP	Fujifilm Corporation	2024-09-04
K232997	EVIS Exera III Gastrointestinal Videoscope GIF-1TH190	Olympus Medical Systems Corporation	2024-06-19