510(k) K050503 ยท FCG Biopsy Needle
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
| Applicant | Olympus Medical Systems Corporation, Melville NY, US |
| Decision | Substantially Equivalent, May 12, 2005 |
| Received | Feb 28, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions Terminated |
FCG | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesio Terminated |
FCG | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural les Terminated |
FCG | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and ext Terminated |
FCG | None listed |
| Oct 7, 2011 | Olympus America Inc. OLYMPUS ViziShot EBUS Aspiration Needle
Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically Terminated |
FCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.