STERILE INSULIN PEN NEEDLE— 510(k) K113186

Substantially Equivalent

Shina Corp.

FDA 510(k) clearance K113186 for STERILE INSULIN PEN NEEDLE, Substantially Equivalent on 2012-04-12. Applicant: Shina Corp..

Clearance details

Applicant: Shina Corp.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2011-10-28
Decision date: 2012-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chungchengnam-Do, KR

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.