Enteral Syringe (20ml, 60ml)— 510(k) K252483

Name: FDA 510(k) clearance K252483
Creator: U.S. Food and Drug Administration
Published: 2026-07-01

Substantially Equivalent

Chirana T.Injecta,A.S.

FDA 510(k) clearance K252483 for Enteral Syringe (20ml, 60ml), Substantially Equivalent on 2026-07-01. Applicant: Chirana T.Injecta,A.S.. Device class: 2.

Clearance details

Applicant: Chirana T.Injecta,A.S.
Product code: Code PNR
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-07
Decision date: 2026-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stará Turá, SK

Download summary PDF View on FDA.gov ↗

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K251585 — Profoject Enteral Feeding Syringe2025-07-18
K243652 — Monoject Enteral Syringe with ENFit Connector (6 models)2024-12-19
K231300 — Nutricair Enteral Syringe with ENFit2023-10-06
K222772 — Oral/Enteral Syringe with ENFit connector2023-08-17

More clearances from Chirana T.Injecta,A.S.

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K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)2026-04-17

Adverse events under product code PNR

product code PNR

Other: 6
Total: 6

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.