Ambu® aScope Colon; Ambu® aBox 2
FDA 510(k) K230332 · Ambu A/S
510(k) numberK230332
Submission
- Device name
- Ambu® aScope Colon; Ambu® aBox 2
- Applicant
- Ambu A/S
Ballerup, DK - Received
- February 7, 2023
- Decision date
- September 15, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDF – Colonoscope 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 colon or rectum 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 FDF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260503 | Triton 1 SystemFDF · Traditional | Neptune Medical, Inc. | 09/03/2026SE |
| K261015 | Solo Scope Colonoscope SystemFDF · Traditional | Gi View, Ltd. | 08/21/2026SE |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101)FDF · Special | BPEndo, LLC | 07/02/2026SE |
| K260423 | Disposable Endoscopic Distal AttachmentsFDF · Traditional | Yangzhou Fartley Medical Instrument Technology… | 05/28/2026SE |
| K252457 | Disposable Distal End Tape HoodFDF · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 01/30/2026SE |
| K244029 | Robopera (ER-R-002); Robopera (ER-R-003)FDF · Traditional | Endorobotics Co., Ltd. | 09/24/2025SE |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…FDF · Traditional | Fujifilm Corporation | 05/23/2025SE |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…FDF · Traditional | Olympus Medical Systems Corporation | 05/15/2025SE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF · Traditional | Pentax of America, Inc. | 01/03/2025SE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF · Traditional | Actuated Medical, Inc. | 10/04/2024SE |
More from Actuated Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K232919 | Ambu® aScope Gastro Large; Ambu® aBox 2FDS · Traditional | 04/05/2024SE |
| 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 |
Questions and answers
When was Ambu® aScope Colon; Ambu® aBox 2 cleared by the FDA?
Ambu® aScope Colon; Ambu® aBox 2 (K230332) received a 510(k) decision of Substantially Equivalent on September 15, 2023, 220 days after the submission was received.
What is the product code of K230332?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.