Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle— 510(k) K181756
Substantially EquivalentApriomed AB
FDA 510(k) clearance K181756 for Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle, Substantially Equivalent on 2018-12-18. Applicant: Apriomed AB.
Clearance details
- Applicant
- Apriomed AB
- Product code
- Code FCG
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Adverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
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.