510(k) K261274 · KTI Bronchoscope Accessory
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes
| Applicant | Cook Ireland, Ltd., Limerick, IE |
| Decision | Substantially Equivalent, Jul 24, 2026 |
| Received | Apr 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261274
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.