# Bioncise NV

- Location (FDA's records): Wellen, BE
- FDA decisions: 1 (2019–2019): 1 510(k) clearance
- Product codes: KNW (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medinvents: 1 (https://510kreport.com/company/medinvents)

## Recent decisions
- K190378: Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix (May 24, 2019)

Source page: https://510kreport.com/company/bioncise