510(k) K012581

REPROCESSED STONE RETRIEVAL BASKETS by Sterilmed, Inc. — Product Code FFL

K012581 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "REPROCESSED STONE RETRIEVAL BASKETS". The FDA issued a decision of Substantially Equivalent on February 14, 2002. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Sterilmed, Inc. has at least 10 other 510(k) clearances on record.