Cleared Traditional

K080764 - SUCCESS CECAL INTUBATION ASSIST

K080764 is an FDA 510(k) clearance for SUCCESS CECAL INTUBATION ASSIST, manufactured by Max Endoscopy, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ODC cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K080764 · Max Endoscopy, Inc. · Gastroenterology & Urology device
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May 2008
Decision
49d
Days
Class 2
Risk

K080764 is an FDA 510(k) clearance for the SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Max Endoscopy, Inc. (Macedonia, US). The FDA issued a Cleared decision on May 6, 2008 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Max Endoscopy, Inc. devices

FDA 510(k) Submission Details - K080764

510(k) Number K080764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2008
Decision Date May 06, 2008
Days to Decision 49 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
81d faster than avg
Panel avg: 130d · This submission: 49d
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 K080764.
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