Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)— 510(k) K252279

Substantially Equivalent

Chirana T.Injecta,A.S.

FDA 510(k) clearance K252279 for Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml), Substantially Equivalent on 2026-04-17. Applicant: Chirana T.Injecta,A.S..

Clearance details

Applicant: Chirana T.Injecta,A.S.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2025-07-22
Decision date: 2026-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
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.