510(k) K180037 ยท FCG Biopsy Needle
Beacon EUS Access System
| Applicant | Covidien, LLC, Mansfield MA, US |
| Decision | Substantially Equivalent, Apr 26, 2018 |
| Received | Jan 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180037
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2020 | Covidien Llc Beacon EUS Access System Preloaded Access 90degree Needle
sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula Open, Classified |
FCG | None listed |
| Aug 5, 2020 | Covidien Llc Beacon EUS Access System Preloaded Access 135degree Needle
sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula Open, Classified |
FCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.