510(k) K031147

OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR by Ethicon Endo-Surgery, Inc. — Product Code KNQ

K031147 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, Inc. for the device "OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR". The FDA issued a decision of Substantially Equivalent on January 12, 2004. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. Ethicon Endo-Surgery, Inc. has at least 10 other 510(k) clearances on record.