510(k) K951600

MILL-ROSE ROTATABLE POLYPECTOMY SNARE by Mill-Rose Laboratory — Product Code FDI

K951600 is an FDA 510(k) premarket notification submitted by Mill-Rose Laboratory for the device "MILL-ROSE ROTATABLE POLYPECTOMY SNARE". The FDA issued a decision of Substantially Equivalent on December 18, 1995. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Mill-Rose Laboratory has at least 10 other 510(k) clearances on record.