Cleared Traditional

K062720 - S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES

K062720 is an FDA 510(k) clearance for S-LINE BIPOLAR RESECTOSCOPES AND BIPOLA..., manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJL cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K062720 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K062720

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 131d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FJL Resectoscope

All 24
Devices cleared under the same product code (FJL) and FDA review panel - the closest regulatory comparables to K062720.
Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
K190099 · Corinth Medtech, Inc. · Mar 2019
Veloxion System
K162979 · Corinth Medtech, Inc. · Mar 2017
AED RESECTOSCOPE
K102663 · National Advanced Endoscopy Devices, Inc. · Dec 2010
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES
K042523 · Richard Wolf Medical Instruments Corp. · Mar 2005
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207
K041610 · Richard Wolf Medical Instruments Corp. · Aug 2004
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
K001270 · Gyrus Medical , Ltd. · Apr 2000
K062720 · S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
Download PDF FDA Summary Richard Wolf Medical …