# K180752: Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole

- Pathway: 510(k) (Traditional)
- Applicant: Corinth Medtech, Inc.
- Decided: Jul 25, 2018 after 125 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933002 (1994). 8 ancestors in all.
2 later devices descend from it; 1 cites 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.
- K022449: Hystereoscopy Pump HM4, W.O.M. World of Medicine AG (2003) Summary page 4.
- K023886: Erbe Vio Esu with Accessories, Model Vio 300 D, Erbe USA, Inc. (2002) Summary page 4.
- K162979: Veloxion System, Corinth Medtech, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K191335: 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), 0 descendants of its own

## Indications for use
The Veloxion System is intended for intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas via suction channel under continuous flow conditions following resection using a bipolar resecting device. It is also intended to distend the uterus by filling with saline to facilitate viewing with a hysteroscope and to monitor the volume differential between fluid flowing into and out of the uterus.

Source page: https://510kreport.com/device/K180752
Methodology: https://510kreport.com/methodology