510(k) K161039

NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) by Neomed, Inc. — Product Code PNR

K161039 is an FDA 510(k) premarket notification submitted by Neomed, Inc. for the device "NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)". The FDA issued a decision of Substantially Equivalent on June 17, 2016. The device falls under product code PNR (Enteral Syringes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Neomed, Inc. has at least 10 other 510(k) clearances on record.