Insignis Syringe Infusion System— 510(k) K232328
Substantially EquivalentInnovative Health Sciences, LLC
FDA 510(k) clearance K232328 for Insignis Syringe Infusion System, Substantially Equivalent on 2024-03-01. Applicant: Innovative Health Sciences, LLC.
Clearance details
- Applicant
- Innovative Health Sciences, LLC
- Product code
- Code FPA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chester, NY, US
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
Source: openFDA MAUDE database, through . 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.