Cleared Traditional

K112698 - CONCENTRIC BALLOON GOOGLE

K112698 is an FDA 510(k) clearance for CONCENTRIC BALLOON GOOGLE, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ODC cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K112698 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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May 2012
Decision
245d
Days
Class 2
Risk

K112698 is an FDA 510(k) clearance for the CONCENTRIC BALLOON GOOGLE. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on May 18, 2012 after a review of 245 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 United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K112698

510(k) Number K112698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2011
Decision Date May 18, 2012
Days to Decision 245 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 131d · This submission: 245d
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 55
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