Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)— 510(k) K252279
Substantially EquivalentChirana 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.. Device class: 2.
Summary
Chirana T.Injecta's Sterile Hypodermic Syringe for Single Use is filed under product code FMF (Syringe, Piston). The name lists four sizes: 20ml, 30ml, 50ml, and 60ml.
Class II, 21 CFR 880.5860. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Chirana T.Injecta filed from Stará Turá, Slovakia. The decision came 269 calendar days after FDA received it (July 22, 2025 to April 17, 2026).
Clearance details
- Applicant
- Chirana T.Injecta,A.S.
- Product code
- Product code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stará Turá, SK
Recent devices under product code FMF
view allMore clearances from Chirana T.Injecta,A.S.
view allAdverse 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, 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.