# K974516: Endolap Resectoscope Cutting Loop 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 Cutting Loop Device is a monopolar electrode designed to deliver radiofrequency energy that is supplied by and electrical generator cleared for medical use. The Endolap Resectoscope Cutting Loop device is indicated for ablation and coagulation of the soft tissue and is intended for use with compatible resectoscopes.

Source page: https://510kreport.com/device/K974516
Methodology: https://510kreport.com/methodology