K-number	K243660
Device name	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-Lock Tip (1183500777); Monoject 60mL Syringe, Luer-Lock Tip (1186000777); Monoject 3mL Syringe, Luer-Lock Tip (8881513934); Monoject 6mL Syringe , Luer-Lock Tip (8881516937); Monojec
Applicant	Cardinalhealth
Product code	FMF
Device class	Class II
Decision date	Aug 22, 2025
Decision	Substantially Equivalent
Regulation	880.5860

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Monoject syringes with Luer-Lock tips in various sizes (1mL to 60mL) are intended for single use by healthcare professionals for general purpose fluid aspiration and/or injection. These are piston syringes regulated under 21 CFR 880.5860.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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