About This 510(k) Submission
K963344 is an FDA 510(k) clearance for the DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE, a Sigmoidoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FAM), submitted by Vision-Sciences, Inc. (Natick, US). The FDA issued a Cleared decision on November 21, 1996, 87 days after receiving the submission on August 26, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.