510(k) K160316 ยท KNW Instrument, Biopsy
SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
| Applicant | M.D.L. S.R.L., Delebio (So), IT |
| Decision | Substantially Equivalent, Oct 27, 2016 |
| Received | Feb 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160316
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2021 | M.D.L. S.r.l. Soft Tissue Biopsy Needles Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.