Cleared Traditional

COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS (K971881) - FDA 510(k) Clearance

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

K971881 · Comeg Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
84d
Days
Class 2
Risk

K971881 is an FDA 510(k) clearance for the COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECT.... Classified as Resectoscope (product code FJL), Class II - Special Controls.

Submitted by Comeg Endoscopy (Aurora, US). The FDA issued a Cleared decision on August 12, 1997 after a review of 84 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 Comeg Endoscopy devices

Submission Details

510(k) Number K971881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1997
Decision Date August 12, 1997
Days to Decision 84 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
46d faster than avg
Panel avg: 130d · This submission: 84d
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 K971881.
KARL STORZ Monopolar Resectoscopes with HF Cable
K232486 · Karl Storz SE & CO. KG · May 2024
KARL STORZ Bipolar Resectoscopes with HF Cable
K221893 · KARL STORZ Endoscopy-America, Inc. · Mar 2023
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
KARL STORZ URETER RESECTOSCOPE
K960757 · KARL STORZ Endoscopy-America, Inc. · May 1996