510(k) K142258

PolyCatch Retrieval Device by Medi-Globe Corporation — Product Code FDI

K142258 is an FDA 510(k) premarket notification submitted by Medi-Globe Corporation for the device "PolyCatch Retrieval Device". The FDA issued a decision of Substantially Equivalent on September 30, 2014. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Medi-Globe Corporation has at least 6 other 510(k) clearances on record.