Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle— 510(k) K203792

Substantially Equivalent

Pikdare Spa

FDA 510(k) clearance K203792 for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle, Substantially Equivalent on 2023-01-20. Applicant: Pikdare Spa.

Clearance details

Applicant: Pikdare Spa
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2020-12-28
Decision date: 2023-01-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Casnate Con Bernate, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.