EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle

The EXEL Disposable Syringe product line includes piston syringes, hypodermic needles, and syringe-needle combinations intended for injecting fluids into or withdrawing fluids from the body, and for administering or aspirating drugs. These devices are designed for use by qualified healthcare professionals in hospital and professional healthcare settings for both adult and pediatric patients.

The subject devices are substantially identical to the predicate in FDA product code, materials, sterilization method, and fundamental design. Key differences include: extended graduation markings on larger syringe volumes (5-50mL); additional needle gauge sizes (27G, 28G, 30G, 31G, 32G, 33G); additional syringe tip configurations (Luer slip eccentric and permanently attached); and an extended 5-year shelf life versus the predicate's 3-year shelf life.

ISO 7886-1:2017 (piston syringes), ISO 7864:2016 (hypodermic needles), ISO 23908:2011 (sharps injury protection), ISO 10993-5/10/11 (biocompatibility), USP <85> (bacterial endotoxins), USP <151> (pyrogen test), and ASTM F1980-07 (accelerated aging).

The subject device shares the same intended use, product codes, and fundamental design principles as the predicate. All differences—extended graduations, additional needle gauges, additional tip configurations, and extended shelf life—were verified through performance testing demonstrating compliance with applicable ISO standards and biocompatibility requirements, and do not raise new safety or effectiveness concerns compared to the predicate.