# K191341: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

- Pathway: 510(k) (Special)
- Applicant: Corinth Medtech, Inc.
- Decided: Jun 13, 2019 after 24 days
- Product code: FJL (Resectoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951972 (1995). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190099: Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Corinth Medtech, Inc. (2019) Summary page 4.
- K062720: S-Line Bipolar Resectoscopes and Bipolar Electrodes, Richard Wolf Medical Instruments Corp. (2007) Summary page 4.
- K042523: Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, Accessories, Richard Wolf Medical Instruments Corp. (2005) Summary page 4.
- K162979: Veloxion System, Corinth Medtech, Inc. (2017) Summary page 4.

## Most influential descendants
- K250522: Multi4 System (2025), 0 descendants of its own

## Indications for use
The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.

Source page: https://510kreport.com/device/K191341
Methodology: https://510kreport.com/methodology