Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
FDA 510(k) clearance K232582 · decided 2023-09-20
Clearance details
- K-number
- K232582
- Device name
- Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
- Applicant
- Ambu A/S
- Decision
- Substantially Equivalent
- Date received
- 2023-08-25
- Decision date
- 2023-09-20
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Ballerup, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US recall (Z-1723-2025) | Ambu Inc. | 2025-05-06 |