Cleared Traditional

K083180 - THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM

K083180 is an FDA 510(k) clearance for THIRD EYE RETROSCOPE AUXILIARY ENDOSCOP..., 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 107-day FDA review.

K083180 · Avantis Medical Systems, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2009
Decision
107d
Days
Class 2
Risk

K083180 is an FDA 510(k) clearance for the THIRD EYE RETROSCOPE 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 February 12, 2009 after a review of 107 days - within the typical 510(k) review window.

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 - K083180

510(k) Number K083180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2008
Decision Date February 12, 2009
Days to Decision 107 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 131d · This submission: 107d
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 109
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K083180.
CLEARPATH
K091305 · Easyglide , Ltd. · Oct 2009
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
K091783 · Avantis Medical Systems, Inc. · Jul 2009
FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
K090116 · Fujinon, Inc. · Apr 2009
PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
K081004 · Stryker GI · May 2008
ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL
K080317 · Syntheon, LLC · Apr 2008
NEOGUIDE ENDOSCOPY SYSTEM
K070622 · Neoguide Systems, Inc. · Aug 2007