Cleared Traditional

K070622 - NEOGUIDE ENDOSCOPY SYSTEM

K070622 is an FDA 510(k) clearance for NEOGUIDE ENDOSCOPY SYSTEM, manufactured by Neoguide Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K070622 · Neoguide Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
161d
Days
Class 2
Risk

K070622 is an FDA 510(k) clearance for the NEOGUIDE ENDOSCOPY SYSTEM. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Neoguide Systems, Inc. (Los Gatos, US). The FDA issued a Cleared decision on August 14, 2007 after a review of 161 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 Neoguide Systems, Inc. devices

FDA 510(k) Submission Details - K070622

510(k) Number K070622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2007
Decision Date August 14, 2007
Days to Decision 161 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 131d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K070622.
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
K083180 · Avantis Medical Systems, Inc. · Feb 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
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
K070330 · Avantis Medical Systems, Inc. · Apr 2007
KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
K063585 · KARL STORZ Endoscopy-America, Inc. · Jan 2007
ENDOGUIDE
K063654 · Kms Medical, LLC · Jan 2007

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.