# K992485: Monopolar Electrodes and Cables - Pathway: 510(k) (Traditional) - Applicant: Us Endo, Inc. - Decided: Aug 27, 1999 after 32 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 Monopalar Electrodes and Accessories are indicated whea Endoscopy is indicated, used primarily to coaguiate issuc, for usc with HF Electrosurgical Units geted Anxtomical sites include primarily, the Abdominal (suprapubic) region. device is reusable, non-sterile, for use as follows: 1. Spatula tip-Dissection-Coagulation & manipulation of liseue . 2. L-Hook tip-Dissection & manipulation 3. J-Hook tip-Carc qui wilh 3 knife