# K953983: Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Oct 2, 1996 after 406 days
- Product code: FAS (Electrode, Electrosurgical, Active, Urological)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Electrodes currently sold by Richard Wolf: named in the summary without a submission number
- (no number) Electrodes sold by ACMI/Circon: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K946377: Electroprobe Single Use Electrosurgical Probes, Ximed Medical Systems (1995). Our OCR of the scanned summary read K946377, FDA’s number for Electroprobe Single Use Electrosurgical Probes (Ximed Medical Systems). Its FDA name has none of the distinctive words the summary uses for the device it names, “Electrodes sold by ProSurg”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K980302: Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes (1998), 19 descendants of its own
- K011496: Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and Forceps Model 8650, 8652, 8660 (2001), 12 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own
- K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (2016), 7 descendants of its own

## Indications for use
The EVAP roller electrodes can be used for removing/vaporization/ablation of soft tissue. For example; on the prostate or on myomas. The electrodes may also be used for coagulation.

Source page: https://510kreport.com/device/K953983
Methodology: https://510kreport.com/methodology