Data / Medical devices / Belgium / Bioncise NV
Bioncise NV: FDA-registered device maker in Wellen Limburg, Belgium, 3 510(k) clearances
Bioncise NV is registered with the FDA (registration 3007513241) in Wellen Limburg, Belgium. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 24, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007513241
- Address
- Bodemstraat 16/3, Wellen Limburg, Belgium, B-3830
- Owner or operator
- Bioncise NV (10028101)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 30, 2008
- Registered through
- 2026
- Brand names listed
- Cervicore, Coramate, Easy Punch, Spirotome, Spirotome Bone
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Curette, Suction, Endometrial (And Accessories) | HHK | 2 | Manufacturer | accessdata.fda.gov |
| Forceps, Surgical, Gynecological | HCZ | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 24, 2019 | K190378 | Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix | KNW | Substantially Equivalent | Bioncise NV | accessdata.fda.gov |
| April 11, 2008 | K080095 | CORAMATE/SPIROTOME SYSTEM | KNW | Substantially Equivalent | Medinvents | accessdata.fda.gov |
| July 13, 2006 | K060384 | CORAMATE/SPIROTOME SYSTEM | KNW | Substantially Equivalent | Medinvents | accessdata.fda.gov |
Compare with other makers
- All makers of Forceps, Surgical, Gynecological
- All makers of Curette, Suction, Endometrial (And Accessories)
- All makers of Instrument, Biopsy
Updated May 24, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.