Cleared Traditional

K041610 - MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207

K041610 is an FDA 510(k) clearance for MORCE SCOPE SET 8970 WITH POWER CONTROL..., 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 65-day FDA review.

K041610 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
65d
Days
Class 2
Risk

K041610 is an FDA 510(k) clearance for the MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207. 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 August 19, 2004 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K041610

510(k) Number K041610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2004
Decision Date August 19, 2004
Days to Decision 65 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
66d faster than avg
Panel avg: 131d · This submission: 65d
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 20
Devices cleared under the same product code (FJL) and FDA review panel - the closest regulatory comparables to K041610.
Veloxion System
K162979 · Corinth Medtech, Inc. · Mar 2017
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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
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS
K971881 · Comeg Endoscopy · Aug 1997
FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
K964892 · Gynecare Innovation Center · Feb 1997
[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
K962506 · Gynecare Innovation Center · Sep 1996