Cleared Special

K112391 - FUJINON COLONOSCOPES (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K112391 · Fujinon, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
342d
Days
Class 2
Risk

K112391 is an FDA 510(k) clearance for the FUJINON COLONOSCOPES. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Fujinon, Inc. (Wayne, US). The FDA issued a Cleared decision on July 26, 2012 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fujinon, Inc. devices

Submission Details

510(k) Number K112391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2011
Decision Date July 26, 2012
Days to Decision 342 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 130d · This submission: 342d
Pathway characteristics
Modification to existing cleared device.

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.

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