Cleared Traditional

Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch (K190099) - FDA 510(k) Clearance

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

K190099 · Corinth Medtech, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
52d
Days
Class 2
Risk

K190099 is an FDA 510(k) clearance for the Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, V.... Classified as Resectoscope (product code FJL), Class II - Special Controls.

Submitted by Corinth Medtech, Inc. (Cupertino, US). The FDA issued a Cleared decision on March 15, 2019 after a review of 52 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 Corinth Medtech, Inc. devices

Submission Details

510(k) Number K190099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2019
Decision Date March 15, 2019
Days to Decision 52 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
78d faster than avg
Panel avg: 130d · This submission: 52d
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 14
Devices cleared under the same product code (FJL) and FDA review panel - the closest regulatory comparables to K190099.
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
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