Cleared Special

K130489 - ELECTRODE, FLEXIBLE SUCTION COAGULATOR (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K130489 · Optim, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
53d
Days
Class 2
Risk

K130489 is an FDA 510(k) clearance for the ELECTRODE, FLEXIBLE SUCTION COAGULATOR. Classified as Electrode, Flexible Suction Coagulator (product code FEH), Class II - Special Controls.

Submitted by Optim, LLC (Sturbridge, US). The FDA issued a Cleared decision on April 19, 2013 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Optim, LLC devices

Submission Details

510(k) Number K130489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2013
Decision Date April 19, 2013
Days to Decision 53 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 130d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FEH Electrode, Flexible Suction Coagulator
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.