Cleared Traditional

K140595 - THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY...

K140595 is an FDA 510(k) clearance for THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY..., manufactured by Avantis Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K140595 · Avantis Medical Systems, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Nov 2014
Decision
255d
Days
Class 2
Risk

K140595 is an FDA 510(k) clearance for the THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Avantis Medical Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 17, 2014 after a review of 255 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 Avantis Medical Systems, Inc. devices

FDA 510(k) Submission Details - K140595

510(k) Number K140595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2014
Decision Date November 17, 2014
Days to Decision 255 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
125d slower than avg
Panel avg: 130d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDF Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K140595.
Fujifilm Video Colonoscope Model EC-600WL V2
K160196 · Fujifilm Medical Systems U.S.A, Inc. · Feb 2016
Balloon controller PB-30
K153483 · Fujifilm Medical Systems U.S.A, Inc. · Dec 2015
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K143732 · Fujifilm Medical Systems U.S.A, Inc. · Jul 2015
FUSE COLONOSCOPY SYSTEM
K141598 · Endochoice, Inc. · Sep 2014
FUSE 1C COLONOSCOPY SYSTEM
K132839 · Endochoice, Inc. · Feb 2014
FUJIFILM 600 SERIES ENDOSCOPES
K132210 · Fujifilm Medical Systems U.S.A, Inc. · Jan 2014