# K973820: Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Circon Corp.
- Decided: May 12, 1998 after 217 days
- Product code: FAS (Electrode, Electrosurgical, Active, Urological)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) American Cystoscope Makers, Inc. Grooved Roller Electrodes: named in the summary without a submission number
- (no number) American Cystoscope Makers, Inc. Resectoscope Cutting Loops: named in the summary without a submission number

## Most influential descendants
- K100275: Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands (2010), 15 descendants of its own
- K152092: Resection Electrodes (2015), 5 descendants of its own
- K102781: Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and Needles, Loops and Bands (2011), 5 descendants of its own
- K093181: Gyrus Acmi PK Button Electrode (2010), 4 descendants of its own
- K171965: Resection Electrodes with HF cable (2017), 3 descendants of its own

## Indications for use
Circon ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome™ Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.

Source page: https://510kreport.com/device/K973820
Methodology: https://510kreport.com/methodology