510(k) K994436

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

K994436 is an FDA 510(k) premarket notification submitted by Surgi-Vision, Inc. for the device "SURGI-VISION ESOPHAGEAL STYLET COIL". The FDA issued a decision of Substantially Equivalent on March 14, 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.