# K974484: Isolated Electrosurgical Probes and Devices-Salinetrode

- Pathway: 510(k) (Traditional)
- Applicant: Ximed/Prosure/Injectx
- Decided: Feb 10, 1998 after 76 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 electrosurgical probes and devices are to be used with commercially available R.F. Generators, endoscopes, and suction. These devices can be used for laparoscopic, hysteroscopic, endoscopic and open surgical procedures designed for soft tissue removal using coagulation/ablation/vaporization mode of R.F. energy.

Source page: https://510kreport.com/device/K974484
Methodology: https://510kreport.com/methodology