Search Results

The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.

The StaClear Syringe is a sterile, single-use, manually operated piston syringe intended for general-purpose aspiration and injection of fluids by trained healthcare professionals. It is suitable for ophthalmic applications, including intravitreal injections. The syringe functions using standard positive-displacement mechanics, in which movement of the plunger creates pressure differentials to aspirate or expel fluid.

The StaClear Syringe is offered in the following configurations:

• SC250AN: Consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and optional plunger cap.
• SC250LS: Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-slip connector, plunger, and plunger stopper.
• SC250LL: Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-lock connector, plunger, and plunger stopper.

All three configurations were previously cleared under K243936. This submission introduces no changes to the device's design, dimensions, materials, or intended use. The only modification is the addition of a rigid PETG tray sealed with a Tyvek lid as an alternative sterile barrier packaging configuration.

The device's intended use, design, materials, sterilization method (EO), and labeled shelf life (5 years) remain unchanged.

N/A

Ask a specific question about this device