510(k) K964100

VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 by Vision-Sciences, Inc. — Product Code FAM

K964100 is an FDA 510(k) premarket notification submitted by Vision-Sciences, Inc. for the device "VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100". The FDA issued a decision of Substantially Equivalent on December 16, 1996. 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.