510(k) K092359 ยท FCG Biopsy Needle
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
| Applicant | Cook Ireland, Ltd., Limerick, IE |
| Decision | Substantially Equivalent, Nov 2, 2009 |
| Received | Aug 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2024 | Cook Medical Incorporated EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 Open, Classified |
FCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.