510(k) K231363

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) by Hantech Medical Device Co., Ltd. — Product Code NGT

K231363 is an FDA 510(k) premarket notification submitted by Hantech Medical Device Co., Ltd. for the device "Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)". The FDA issued a decision of Substantially Equivalent on September 27, 2023. The device falls under product code NGT (Saline, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Hantech Medical Device Co., Ltd. has at least 4 other 510(k) clearances on record.