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

Substantially Equivalent

Chirana T.Injecta,A.S.

Clearance details

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

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.