Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix— 510(k) K190378

Substantially Equivalent

Bioncise NV

FDA 510(k) clearance K190378 for Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix, Substantially Equivalent on 2019-05-24. Applicant: Bioncise NV.

Clearance details

Applicant: Bioncise NV
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2019-02-19
Decision date: 2019-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellen, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.