# K970961: Vaporization Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Apr 10, 1998 after 389 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
Longest line of descent: 1 generation back to K953983 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953983: Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue, Richard Wolf Medical Instruments Corp. (1996) Summary page 2.
- (no number) Circon model VE-B: named in the summary without a submission number
- (no number) ProSurg model SB-24W: named in the summary without a submission number
- (no number) ACMI/Circon: named in the summary without a submission number

## Indications for use
These specific EVAP electrodes can be used for vaporization, ablation, coagulation, and or resection of soft tissue in the urology tract and/or fibroids or myomas. The electrodes can be used for endometrial ablation and endometriosis.

Source page: https://510kreport.com/device/K970961
Methodology: https://510kreport.com/methodology