510(k) K072466

STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 by Scican , Ltd. — Product Code FLE

K072466 is an FDA 510(k) premarket notification submitted by Scican , Ltd. for the device "STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101". The FDA issued a decision of Substantially Equivalent on December 19, 2007. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Scican , Ltd. has at least 10 other 510(k) clearances on record.