# K964594: Vaportrode Vaporization Electrode -Grooved/Fluted/Spiked (Gve-B,Gve-F,Gve-S) & Vaportomme Vaporization Loop (Gve-LG)

- Pathway: 510(k) (Traditional)
- Applicant: Circon Corp.
- Decided: Aug 15, 1997 after 273 days
- Product code: KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The primary indications for use are abnormal uterine bleeding with or without pain, and infertility. Vaporization electrodes intended uses in gynecology, along with other resectoscopic electrodes and instruments, are: transuterine resection of fibroids, endometrial ablation, resectoscopic management of Miillerian fusion defects, resectoscopic management of intrauterine lesions, resectoscopic management of intractable uterine bleeding.

Source page: https://510kreport.com/device/K964594
Methodology: https://510kreport.com/methodology