510(k) K162648

U-Blade Veress Needle by Tianjin Uwell Medical Device Manufacturing Co., Ltd. — Product Code HIF

K162648 is an FDA 510(k) premarket notification submitted by Tianjin Uwell Medical Device Manufacturing Co., Ltd. for the device "U-Blade Veress Needle". The FDA issued a decision of Substantially Equivalent on Dec 12, 2016. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Tianjin Uwell Medical Device Manufacturing Co., Ltd. has 1 other 510(k) clearance on record.