Cleared Traditional

K903162 - FLEXIBLE ENDOSCOPIC ELECTRODES

K903162 is the FDA 510(k) clearance for FLEXIBLE ENDOSCOPIC ELECTRODES by North American Sterilization & Packaging Co.. It is a Class 2 Gastroenterology & Urology device (product code FAS) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K903162 · North American Sterilization & Packaging Co. · Gastroenterology & Urology device
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Dec 1990
Decision
153d
Days
Class 2
Risk

K903162 is an FDA 510(k) clearance for the FLEXIBLE ENDOSCOPIC ELECTRODES. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by North American Sterilization & Packaging Co. (Sparta, US). The FDA issued a Cleared decision on December 18, 1990 after a review of 153 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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.

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Submission Details

510(k) Number K903162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1990
Decision Date December 18, 1990
Days to Decision 153 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 130d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAS Electrode, Electrosurgical, Active, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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.