The following data is part of a premarket notification filed by Bioncise Nv with the FDA for Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge With 10 Mm Helix.
| Device ID | K190378 |
| 510k Number | K190378 |
| Device Name: | Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge With 10 Mm Helix |
| Classification | Instrument, Biopsy |
| Applicant | Bioncise NV Bodemstraat 16 Wellen, BE 3500 |
| Contact | Jaak Janssens |
| Correspondent | Jaak Janssens Bioncise NV Bodemstraat 16 Wellen, BE 3830 |
| Product Code | KNW |
| Subsequent Product Code | HCZ |
| Subsequent Product Code | HHK |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-05-24 |