Cleared Traditional

K103155 - SUMO ACCESS AND TISSUE RESECTION SYSTEM (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103155 · Apollo Endosurgery, Inc. · Gastroenterology & Urology device
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Oct 2011
Decision
367d
Days
Class 2
Risk

K103155 is an FDA 510(k) clearance for the SUMO ACCESS AND TISSUE RESECTION SYSTEM. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Apollo Endosurgery, Inc. (Austin, US). The FDA issued a Cleared decision on October 28, 2011 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Apollo Endosurgery, Inc. devices

Submission Details

510(k) Number K103155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2010
Decision Date October 28, 2011
Days to Decision 367 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 130d · This submission: 367d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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All 70
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