# K972856: Ultra-Fine Diathermy Loop and Coagulation Balls

- Pathway: 510(k) (Traditional)
- Applicant: Rocket Medical Plc
- Decided: Feb 11, 1998 after 194 days
- Product code: KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4160
- 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. The FDA summary names no predicate by number.

## Indications for use
Large Loop Excision of the Transformation zone in the Diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN I, IL, III) and Cervical Dysplasia Extrenal Anogenital Lesions. Cervical Conizations. Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.

Source page: https://510kreport.com/device/K972856
Methodology: https://510kreport.com/methodology