510(k) K190378 ยท KNW Instrument, Biopsy
Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
| Applicant | Bioncise NV, Wellen, BE |
| Decision | Substantially Equivalent, May 24, 2019 |
| Received | Feb 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190378
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.