# K143475: VAPR Tripolar Suction Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek
- Decided: Apr 3, 2015 after 119 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 11 generations back to K931783 (1993). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113545: Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System Coolpluse 90 and Coolpluse 90 with Han, Depuy Mitek, A Johnson & Johnson Company (2012) Summary page 5.
- K100638: Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214, Depuy Mitek, A Johnson & Johnson Company (2010) Summary page 5.

## Recalls of this device
- Nov 23, 2015 · Class II · Z-0479-2016: Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the no

## Indications for use
The VAPR Electrodes, for use with the VAPR VUE Radiofrequency System, are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

Source page: https://510kreport.com/device/K143475
Methodology: https://510kreport.com/methodology