510(k) K191976 ยท FMI Needle, Hypodermic, Single Lumen
Piper GO-IO Intraosseous Infusion System
| Applicant | Piper Access, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Nov 13, 2019 |
| Received | Jul 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191976
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Bard Access Systems, Inc. BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK,
BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK,
BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK,
BD Needle Kit Open, Classified |
FMI | None listed |
| Jul 22, 2022 | Bard Access Systems, Inc. Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga,
D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga,
D015251NK/ BD Needle Kit for Power Open, Classified |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.