# K120095: Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode with Hand Controls, S90 with Hand

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Apr 6, 2012 after 85 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931783 (1993). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002422: Varpr 3.5MM 90 Suction Electrode for Use with Vapr System, Mitek Products (2000) Summary page 1.
- K082643: 3.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side Effect Electrode with Integrate, Depuy Mitek, A Johnson & Johnson Company (2008) Summary page 1.
- K100638: Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214, Depuy Mitek, A Johnson & Johnson Company (2010) Summary page 2.
- K041135: Vapr 3 Electrosurgical System and Vapr LD and LP Suction Electrodes, Depuy Mitek, A Johnson & Johnson Company (2004) Summary page 2.
- K963783: Mitek Electrosurgical System for Arthroscopic Use, ETHICON, Inc. (1996) Summary page 2.

## Indications for use
The DePuy Mitek VAPR Electrodes for use with the VAPR System are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

Source page: https://510kreport.com/device/K120095
Methodology: https://510kreport.com/methodology