Cleared Traditional

K090116 - FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15

K090116 is an FDA 510(k) clearance for FUJINON COLONOSCOPE FOR DOUBLE BALLOON ..., manufactured by Fujinon, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K090116 · Fujinon, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
91d
Days
Class 2
Risk

K090116 is an FDA 510(k) clearance for the FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Fujinon, Inc. (Kita- Ku Saitama, JP). The FDA issued a Cleared decision on April 22, 2009 after a review of 91 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 Fujinon, Inc. devices

FDA 510(k) Submission Details - K090116

510(k) Number K090116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date April 22, 2009
Days to Decision 91 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
40d faster than avg
Panel avg: 131d · This submission: 91d
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 100
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K090116.
EUS BALLOON
K111028 · United States Endoscopy Group, Inc. · Nov 2011
UPD-Y0003
K103312 · Olympus Medical Systems Corporation · May 2011
OLYMPUS CF TYPE Y0023-L, Y0023I
K101053 · Olympus Medical Systems Corporation · Jul 2010
PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
K081004 · Stryker GI · May 2008
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K080317 · Syntheon, LLC · Apr 2008
NEOGUIDE ENDOSCOPY SYSTEM
K070622 · Neoguide Systems, Inc. · Aug 2007