510(k) K984363

XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM by Xomed, Inc. — Product Code BTA

K984363 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM". The FDA issued a decision of Substantially Equivalent on February 26, 1999. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Xomed, Inc. has at least 10 other 510(k) clearances on record.