Cleared Traditional

VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100

K964100 · Vision-Sciences, Inc. · Gastroenterology & Urology

Dec 1996

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K964100 is an FDA 510(k) clearance for the VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100, 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 December 16, 1996, 66 days after receiving the submission on October 11, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K964100 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 1996
Decision Date	December 16, 1996
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FAM — Sigmoidoscope And Accessories, Flexible/rigid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Examine And Perform Procedures Within The Sigmoid (descending) Colon