510(k) K212033

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle by Shandong Zhushi Pharmaceutical Group Co., Ltd. — Product Code FMF

K212033 is an FDA 510(k) premarket notification submitted by Shandong Zhushi Pharmaceutical Group Co., Ltd. for the device "Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle". The FDA issued a decision of Substantially Equivalent on August 17, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Shandong Zhushi Pharmaceutical Group Co., Ltd. has at least 7 other 510(k) clearances on record.