510(k) K963344

DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE by Vision-Sciences, Inc. — Product Code FAM

K963344 is an FDA 510(k) premarket notification submitted by Vision-Sciences, Inc. for the device "DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE". The FDA issued a decision of Substantially Equivalent on November 21, 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.