510(k) K885168

RUBENSTEIN URETERAL STONE FRAGMENT BRUSH by Boston Scientific Corp — Product Code FGO

K885168 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "RUBENSTEIN URETERAL STONE FRAGMENT BRUSH". The FDA issued a decision of Substantially Equivalent on September 8, 1989. The device falls under product code FGO (Dislodger, Stone, Flexible), a Class II device regulated under 21 CFR 876.4680. Boston Scientific Corp has at least 10 other 510(k) clearances on record.