Cleared Traditional

K150852 - SIC 8000

K150852 is an FDA 510(k) clearance for SIC 8000, manufactured by Cosmo Technologies, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code PLL cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K150852 · Cosmo Technologies, Ltd. · Gastroenterology & Urology device
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Sep 2015
Decision
156d
Days
Class 2
Risk

K150852 is an FDA 510(k) clearance for the SIC 8000. Classified as Submucosal Injection Agent (product code PLL), Class II - Special Controls.

Submitted by Cosmo Technologies, Ltd. (Dublin 1, IE). The FDA issued a Cleared decision on September 3, 2015 after a review of 156 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 Cosmo Technologies, Ltd. devices

FDA 510(k) Submission Details - K150852

510(k) Number K150852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2015
Decision Date September 03, 2015
Days to Decision 156 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
26d slower than avg
Panel avg: 130d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLL Device Classification - Class 2, Special Controls

Product Code PLL Submucosal Injection Agent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Intended For Use In Gastrointestinal Endoscopic Procedures For Submucosal Lift Of Polyps, Adenomas, Early-stage Cancers Or Other Gastrointestinal Mucosal Lesions, Prior To Excision With A Snare Or Endoscopic Device.
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.