Insulin Syringes— 510(k) K242434

Substantially Equivalent

Chirana T. Injecta

FDA 510(k) clearance K242434 for Insulin Syringes, Substantially Equivalent on 2024-12-24. Applicant: Chirana T. Injecta.

Clearance details

Applicant: Chirana T. Injecta
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2024-08-16
Decision date: 2024-12-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Stará Turá, SK

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.