510(k) K232582 · EOQ Bronchoscope (Flexible Or Rigid)
Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set
| Applicant | Ambu A/S, Ballerup, DK |
| Decision | Substantially Equivalent, Sep 20, 2023 |
| Received | Aug 25, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232582
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2025 | Ambu Inc. Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.