FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Ambu® aScope Gastro Large; Ambu® aBox 2
K Number: K232919
·
Decision Apr 5, 2024
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
74
Applicant Total
38
Review Days
199
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Basic Information
- Device Name
- Ambu® aScope Gastro Large; Ambu® aBox 2
- K Number
- K232919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ambu A/S
- Date Received
- September 19, 2023
- Decision Date
- April 5, 2024
- Product Code
- FDS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FDS | Gastroscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Ambu A/S
| K Number | Device Name | ||
|---|---|---|---|
| K251583 | Ambu® Virobac II® Exhalation Filter | Apr 30, 2026 | Substantially Equivalent |
| K250269 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) | Jun 11, 2025 | Substantially Equivalent |
| K240849 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2 | Oct 16, 2024 | Substantially Equivalent |
| K240848 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance | Oct 10, 2024 | Substantially Equivalent |
| K242108 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance | Aug 16, 2024 | Substantially Equivalent |
| K233630 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2 | Jun 24, 2024 | Substantially Equivalent |
| K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2 | Apr 16, 2024 | Substantially Equivalent |
| K233671 | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance | Jan 4, 2024 | Substantially Equivalent |
| K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Sep 20, 2023 | Substantially Equivalent |
| K230332 | Ambu® aScope Colon; Ambu® aBox 2 | Sep 15, 2023 | Substantially Equivalent |