Cleared Traditional

K943715 - VISION SYSTEM UPPER G.I. EXDOSCOPE

K943715 is the FDA 510(k) clearance for VISION SYSTEM UPPER G.I. EXDOSCOPE by Vision-Sciences, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDS) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K943715 · Vision-Sciences, Inc. · Gastroenterology & Urology device
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Feb 1995
Decision
207d
Days
Class 2
Risk

K943715 is an FDA 510(k) clearance for the VISION SYSTEM UPPER G.I. EXDOSCOPE. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Vision-Sciences, Inc. (Natick, US). The FDA issued a Cleared decision on February 24, 1995 after a review of 207 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vision-Sciences, Inc. devices

Submission Details

510(k) Number K943715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1994
Decision Date February 24, 1995
Days to Decision 207 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 130d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FDS Gastroscope And Accessories, Flexible/rigid

All 56
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K943715.
EG-3400, VIDEO GASTROSCOPE
K962897 · Pentax Precision Instrument Corp. · Oct 1996
EG-3800T, VIDEO GASTROSCOPE
K962460 · Pentax Precision Instrument Corp. · Sep 1996
EG-2940, VIDEO GASTROSCOPE
K961564 · Pentax Precision Instrument Corp. · Jul 1996
OLYMPUS MEASURING DEVICES
K933717 · Olympus Corp. · Nov 1993
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
K850020 · Pentax Precision Instrument Corp. · Jul 1985
TWO CHANNEL GASTROFIBERSCOPE FG-36T
K833924 · Pentax Precision Instrument Corp. · Feb 1984