Cleared Traditional

K090851 - DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS A...

K090851 is an FDA 510(k) clearance for DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS A..., manufactured by Byrne Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ODC cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K090851 · Byrne Medical, Inc. · Gastroenterology & Urology device
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Jul 2009
Decision
94d
Days
Class 2
Risk

K090851 is an FDA 510(k) clearance for the DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100.... Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Byrne Medical, Inc. (Conroe, US). The FDA issued a Cleared decision on July 2, 2009 after a review of 94 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 Byrne Medical, Inc. devices

FDA 510(k) Submission Details - K090851

510(k) Number K090851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2009
Decision Date July 02, 2009
Days to Decision 94 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 130d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODC Device Classification - Class 2, Special Controls

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 51
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K090851.
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BioGuard Air/Water Valve, BioGuard Suction Valve
K151345 · United States Endoscopy Group, Inc. · Aug 2015
CONCENTRIC BALLOON GOOGLE
K112698 · United States Endoscopy Group, Inc. · May 2012
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431
K073484 · Ethicon Endo-Surgery, Inc. · Mar 2008
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · Boston Scientific Corp · Mar 2001