Cleared Traditional

K190099 - Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch

K190099 is an FDA 510(k) clearance for Veloxion Controller Kit, manufactured by Corinth Medtech, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJL cleared through the Traditional 510(k) pathway after a 52-day FDA review.

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

FDA 510(k) Submission Details - K190099

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
79d faster than avg
Panel avg: 131d · This submission: 52d
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 22
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
Veloxion System
K162979 · Corinth Medtech, Inc. · Mar 2017
AED RESECTOSCOPE
K102663 · National Advanced Endoscopy Devices, Inc. · Dec 2010
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
K062720 · Richard Wolf Medical Instruments Corp. · Mar 2007