510(k) K181426

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) by Jiangsu Micsafe Medical Technology Co., Ltd. — Product Code PNR

K181426 is an FDA 510(k) premarket notification submitted by Jiangsu Micsafe Medical Technology Co., Ltd. for the device "Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)". The FDA issued a decision of Substantially Equivalent on October 11, 2018. The device falls under product code PNR (Enteral Syringes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Jiangsu Micsafe Medical Technology Co., Ltd. has at least 4 other 510(k) clearances on record.