Cleared Traditional

MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 (K041610) - FDA 510(k) Clearance

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

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

Submission Details

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
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 130d · This submission: 65d
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 23
Devices cleared under the same product code (FJL) and FDA review panel - the closest regulatory comparables to K041610.
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KARL STORZ URETER RESECTOSCOPE
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