Cleared Traditional

K062720 - S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062720 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
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Mar 2007
Decision
191d
Days
Class 2
Risk

K062720 is an FDA 510(k) clearance for the S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES. Classified as Resectoscope (product code FJL), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on March 22, 2007 after a review of 191 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 Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K062720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2006
Decision Date March 22, 2007
Days to Decision 191 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
61d slower than avg
Panel avg: 130d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJL Resectoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.