Ambu® aScope Gastro Large; Ambu® aBox 2
FDA 510(k) K232919 · Ambu A/S
510(k) numberK232919
Submission
- Device name
- Ambu® aScope Gastro Large; Ambu® aBox 2
- Applicant
- Ambu A/S
Ballerup, DK - Received
- September 19, 2023
- Decision date
- April 5, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDS – Gastroscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FDS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260856 | Disposable Distal Attachment D-201-13404FDS · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional | Intuitive Surgical, Inc. | 08/07/2026SE |
| K260573 | EvoEndo Single-Use Endoscopy SystemFDS · Traditional | EvoEndo, Inc. | 04/21/2026SE |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS · Traditional | Fujifilm Corporation | 02/17/2026SE |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…FDS · Special | Fujifilm Corporation | 02/06/2026SE |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…FDS · Traditional | Pentax of America, Inc. | 12/16/2025SE |
| K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100FDS · Traditional | Actuated Medical, Inc. | 10/31/2025SE |
| K251708 | EvoEndo Single-Use Endoscopy SystemFDS · Traditional | EvoEndo, Inc. | 10/10/2025SE |
| K243388 | Disposable Distal CapFDS · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 06/27/2025SE |
More from Micro-Tech (Nanjing) Co., Ltd.
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| K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US)…GXY · Traditional | 07/14/2026SE |
| K251583 | Ambu® Virobac II® Exhalation FilterCAH · Traditional | 04/30/2026SE |
| K250269 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse…FAJ · Traditional | 06/11/2025SE |
| K240849 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse…FAJ · Traditional | 10/16/2024SE |
| K240848 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse…FAJ · Traditional | 10/10/2024SE |
| K242108 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse…FGB · Special | 08/16/2024SE |
| K233630 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse…FGB · Traditional | 06/24/2024SE |
| K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2FDT · Traditional | 04/16/2024SE |
| K233671 | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 AdvanceEOQ · Special | 01/04/2024SE |
| K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler SetEOQ · Special | 09/20/2023SE |
Questions and answers
When was Ambu® aScope Gastro Large; Ambu® aBox 2 cleared by the FDA?
Ambu® aScope Gastro Large; Ambu® aBox 2 (K232919) received a 510(k) decision of Substantially Equivalent on April 5, 2024, 199 days after the submission was received.
What is the product code of K232919?
The FDA product code is FDS – Gastroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.