# K993777: Disposable and Reusable Ball and Loop Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: R-Group Intl.
- Decided: May 25, 2000 after 199 days
- Product code: HGI (Electrocautery, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4120
- 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 loop electrodes are designed for the LEEP or LLETZ procedure, which is performed to remove a lesion of abnormal cells from the cervix. The loop electrode is aftached to an electrosurgical generator that emits an electrical current used to cut away the affected tissue, Following the removal of the cells in the affected area the ball electrode is used to seal the area and stop any bleeding that may have occurred. Some indications for use are: Cervical conizations Large Loop Excision of the Transformation Zone (LLETZ) in the Diagnosis and Treatment of some Cetvical Intraepithelial Neoplasias (CIN) and Dysplasias. c. External Anogenital Lesions d. Large Vaginal Intraepithelial Neoplasic (VAIN) Lesions.

Source page: https://510kreport.com/device/K993777
Methodology: https://510kreport.com/methodology