Cleared Traditional

K110088 - DEFENDO Y-OPSY IRRIGATOR

K110088 is an FDA 510(k) clearance for DEFENDO Y-OPSY IRRIGATOR, manufactured by Byrne Medical Incorporated. The device is a Class 2 Gastroenterology & Urology device with product code ODC cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K110088 · Byrne Medical Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
149d
Days
Class 2
Risk

K110088 is an FDA 510(k) clearance for the DEFENDO Y-OPSY IRRIGATOR. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Byrne Medical Incorporated (Conroe, US). The FDA issued a Cleared decision on June 10, 2011 after a review of 149 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 Incorporated devices

FDA 510(k) Submission Details - K110088

510(k) Number K110088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2011
Decision Date June 10, 2011
Days to Decision 149 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
18d slower than avg
Panel avg: 131d · This submission: 149d
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 64
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K110088.
NAVIAID ICVI-F,S,B,R DEVICE
K112106 · Smart Medical Systems , Ltd. · Feb 2012
NAVIAID(TM) BGC DEVICE
K111760 · Smart Medical Systems , Ltd. · Aug 2011
NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE
K110291 · Smart Medical Systems , Ltd. · Jun 2011
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
K102581 · Byrne Medical, Inc. · Nov 2010
DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304
K102409 · Byrne Medical, Inc. · Nov 2010
CLEARJET
K101094 · Easyglide , Ltd. · May 2010