510(k) K002345

SURGI-VISION URETHRAL COIL by Surgi-Vision, Inc. — Product Code MOS

K002345 is an FDA 510(k) premarket notification submitted by Surgi-Vision, Inc. for the device "SURGI-VISION URETHRAL COIL". The FDA issued a decision of Substantially Equivalent on October 11, 2000. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Surgi-Vision, Inc. has at least 8 other 510(k) clearances on record.