Cleared Traditional

K201789 - CT-STOR

K201789 is an FDA 510(k) clearance for CT-STOR, manufactured by Energy Delivery Solutions. The device is a Class 2 Gastroenterology & Urology device with product code NDS cleared through the Traditional 510(k) pathway after a 447-day FDA review.

K201789 · Energy Delivery Solutions · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Energy Delivery Solutions devices

FDA 510(k) Submission Details - K201789

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
316d slower than avg
Panel avg: 131d · This submission: 447d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NDS Media, Culture, Ex Vivo, Tissue And Cell

All 8
Devices cleared under the same product code (NDS) and FDA review panel - the closest regulatory comparables to K201789.
MSC SFM
K232543 · Yocon Biology Technology Company · Sep 2024
“MoFi” Cell Culture Basal Medium
K240247 · Duogenic Stemcells Corporation · Jul 2024
PRIME-XV FreezIS DMSO-Free MD
K231804 · Fujifilm Irvine Scientific · Nov 2023
OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
K113566 · Life Technologies, Inc. · Jun 2012
STEMPRO MSC SFM
K103302 · Life Technologies Corporation · Feb 2011
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
K100616 · Life Technologies Corporation · May 2010