# K991830: Capsular Shrinkage Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Aug 20, 1999 after 84 days
- Product code: JOS (Electrode, Electrosurgical)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963157 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984185: Modification to Tac-S Monopolar Cautery Probe Family, Oratec Interventions, Inc. (1998) Summary page 3.
- (no number) ArthoWand CAPS: named in the summary without a submission number

## Recalls of this device
- Aug 29, 2016 · Class II · Z-0085-2017: CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk 

## Indications for use
The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.

Source page: https://510kreport.com/device/K991830
Methodology: https://510kreport.com/methodology