Cleared Traditional

AED RESECTOSCOPE (K102663) - FDA 510(k) Clearance

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

K102663 · National Advanced Endoscopy Devices, Inc. · Gastroenterology & Urology device
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Dec 2010
Decision
106d
Days
Class 2
Risk

K102663 is an FDA 510(k) clearance for the AED RESECTOSCOPE. Classified as Resectoscope (product code FJL), Class II - Special Controls.

Submitted by National Advanced Endoscopy Devices, Inc. (Canoga Park, US). The FDA issued a Cleared decision on December 30, 2010 after a review of 106 days - within the typical 510(k) review window.

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 National Advanced Endoscopy Devices, Inc. devices

Submission Details

510(k) Number K102663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2010
Decision Date December 30, 2010
Days to Decision 106 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
24d faster than avg
Panel avg: 130d · This submission: 106d
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.

Regulatory Peers - FJL Resectoscope

All 15
Devices cleared under the same product code (FJL) and FDA review panel - the closest regulatory comparables to K102663.
Veloxion System
K230205 · Corinth Medtech, Inc. · Feb 2023
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
K191341 · Corinth Medtech, Inc. · Jun 2019
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
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
K062720 · Richard Wolf Medical Instruments Corp. · Mar 2007
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