ClearanceBrief
510(k) K243660 · FMF Syringe, Piston

Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer

ApplicantCardinalhealth, Waukegan IL, US
DecisionSubstantially Equivalent, Aug 22, 2025
ReceivedNov 27, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243660

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.