510(k) K964326

VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM by Vision-Sciences, Inc. — Product Code FAM

K964326 is an FDA 510(k) premarket notification submitted by Vision-Sciences, Inc. for the device "VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM". The FDA issued a decision of Substantially Equivalent on January 3, 1997. The device falls under product code FAM (Sigmoidoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Vision-Sciences, Inc. has at least 10 other 510(k) clearances on record.