# K162979: Veloxion System

- Pathway: 510(k) (Traditional)
- Applicant: Corinth Medtech, Inc.
- Decided: Mar 24, 2017 after 149 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: 2 generations back to K933002 (1994). 3 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042523: Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, Accessories, Richard Wolf Medical Instruments Corp. (2005) Summary page 4.
- K023886: Erbe Vio Esu with Accessories, Model Vio 300 D, Erbe USA, Inc. (2002) Summary page 4.

## Most influential descendants
- K190099: Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch (2019), 3 descendants of its own
- K180752: Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole (2018), 2 descendants of its own
- 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 (2019), 1 descendant of its own
- K190113: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (2019), 1 descendant of its own
- K250522: Multi4 System (2025), 0 descendants of its own

## Indications for use
The Veloxion System is intended for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.

Source page: https://510kreport.com/device/K162979
Methodology: https://510kreport.com/methodology