# K974515: Endolap Resectoscope Roller Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Endolap, Inc.
- Decided: Dec 22, 1997 after 20 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.
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 Endolap Resectoscope Roller Electrode device is a surgical electrode designed to deliver radio frequency current supplied by an electrical generator cleared for such use. The Endolap Resectoscope roller electrode is indicated for ablation and coagulation of the soft tissue and is intended for use with compatible resectoscopes.

Source page: https://510kreport.com/device/K974515
Methodology: https://510kreport.com/methodology