Cleared Traditional

K964100 - VISION-SCIENCES MODEL SS-U32 ENDO SHEAT...

K964100 is the FDA 510(k) clearance for VISION-SCIENCES MODEL SS-U32 ENDO SHEAT... by Vision-Sciences, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAM) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K964100 · Vision-Sciences, Inc. · Gastroenterology & Urology device
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Dec 1996
Decision
66d
Days
Class 2
Risk

K964100 is an FDA 510(k) clearance for the VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE.... Classified as Sigmoidoscope And Accessories, Flexible/rigid (product code FAM), Class II - Special Controls.

Submitted by Vision-Sciences, Inc. (Natick, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vision-Sciences, Inc. devices

Submission Details

510(k) Number K964100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 130d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAM Sigmoidoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Sigmoid (descending) Colon
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAM Sigmoidoscope And Accessories, Flexible/rigid

All 11
Devices cleared under the same product code (FAM) and FDA review panel - the closest regulatory comparables to K964100.
VS-100 VIDEO SIGMOIDOSCOPE
K970382 · Welch Allyn, Inc. · Apr 1997
ES-3840, VIDEO SIGMOIDOSCOPE
K961567 · Pentax Precision Instrument Corp. · Jun 1996
ES-3800, VIDEO SIGMOIDOSCOPE
K951577 · Pentax Precision Instrument Corp. · Mar 1996
VIDEO SIGMOIDOSCOPE
K950429 · Welch Allyn, Inc. · Aug 1995
FS-34P2, FIBER SIGMOIDOSCOPE
K951576 · Pentax Precision Instrument Corp. · Jun 1995
FS-38X, FIBER SIGMOIDOSCOPE
K951572 · Pentax Precision Instrument Corp. · Jun 1995