Cleared Traditional

K050454 - OMNITECH FULGURATING ELECTRODE

K050454 is an FDA 510(k) clearance for OMNITECH FULGURATING ELECTRODE, manufactured by Omnitech Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAS cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K050454 · Omnitech Systems, Inc. · Gastroenterology & Urology device
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May 2005
Decision
94d
Days
Class 2
Risk

K050454 is an FDA 510(k) clearance for the OMNITECH FULGURATING ELECTRODE. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Omnitech Systems, Inc. (Valparaiso, US). The FDA issued a Cleared decision on May 27, 2005 after a review of 94 days - within the typical 510(k) review window.

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.

View all Omnitech Systems, Inc. devices

FDA 510(k) Submission Details - K050454

510(k) Number K050454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2005
Decision Date May 27, 2005
Days to Decision 94 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 131d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FAS Electrode, Electrosurgical, Active, Urological

All 41
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