510(k) K130616 ยท KNW Instrument, Biopsy
MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES
| Applicant | Biopsybell S.R.L., Verona NJ, US |
| Decision | Substantially Equivalent, Feb 7, 2014 |
| Received | Mar 7, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130616
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2021 | BIOPSYBELL S.R.L. BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111 Terminated |
KNW | None listed |
| Mar 25, 2021 | Zavation 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.