510(k) K112945 ยท KNW Instrument, Biopsy
ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
| Applicant | Inrad, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Nov 3, 2011 |
| Received | Oct 4, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112945
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2015 | Stryker Instruments Div. of Stryker Corporation EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip. Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.