510(k) K201284

Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use by Set Medikal Sanayi VE Ticaret Anonim Sirketi — Product Code FMF

K201284 is an FDA 510(k) premarket notification submitted by Set Medikal Sanayi VE Ticaret Anonim Sirketi for the device "Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use". The FDA issued a decision of Substantially Equivalent on Dec 14, 2020. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Set Medikal Sanayi VE Ticaret Anonim Sirketi has 1 other 510(k) clearance on record.