Cleared Traditional

K201789 - CT-STOR (FDA 510(k) Clearance)

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

K201789 · Energy Delivery Solutions · Gastroenterology & Urology device
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Sep 2021
Decision
447d
Days
Class 2
Risk

K201789 is an FDA 510(k) clearance for the CT-STOR. Classified as Media, Culture, Ex Vivo, Tissue And Cell (product code NDS), Class II - Special Controls.

Submitted by Energy Delivery Solutions (Jeffersonville, US). The FDA issued a Cleared decision on September 20, 2021 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5885 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

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Submission Details

510(k) Number K201789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2020
Decision Date September 20, 2021
Days to Decision 447 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
317d slower than avg
Panel avg: 130d · This submission: 447d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDS Media, Culture, Ex Vivo, Tissue And Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5885
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.