Insulia Bolus Companion— 510(k) K232451

Substantially Equivalent

Voluntis Sa.

FDA 510(k) clearance K232451 for Insulia Bolus Companion, Substantially Equivalent on 2023-12-12. Applicant: Voluntis Sa..

Clearance details

Applicant: Voluntis Sa.
Product code: Code NDC
Advisory panel: Anesthesiology
Date received: 2023-08-14
Decision date: 2023-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suresnes, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

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.