Cleared Traditional

K943895 - VISION SYSTEM COLONSCOPE

K943895 is the FDA 510(k) clearance for VISION SYSTEM COLONSCOPE by Vision-Sciences, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDF) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K943895 · Vision-Sciences, Inc. · Gastroenterology & Urology device
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Feb 1995
Decision
178d
Days
Class 2
Risk

K943895 is an FDA 510(k) clearance for the VISION SYSTEM COLONSCOPE. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Vision-Sciences, Inc. (Natick, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 178 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 K943895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1994
Decision Date February 03, 1995
Days to Decision 178 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
48d slower than avg
Panel avg: 130d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum 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 - FDF Colonoscope And Accessories, Flexible/rigid

All 60
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K943895.
FC-38TLH, FIBER COLONOSCOPE
K951575 · Pentax Precision Instrument Corp. · Jun 1995
FC-38LX, FIBER COLONOSCOPE
K951578 · Pentax Precision Instrument Corp. · Jun 1995
FC-38LH, FIBER COLONOSCCOPE
K951580 · Pentax Precision Instrument Corp. · Jun 1995
SULLIVAN VARIABLE STIFFNESS CABLE
K901610 · Wilson-Cook Medical, Inc. · Jun 1990
COLONOSCOPE GUIDING TUBE DEVICE
K884857 · Mill-Rose Laboratory · Mar 1989
PENTAX FC-38LA & FC-38SA COLONOFIBER
K822846 · Pentax Precision Instrument Corp. · Oct 1982