# K082643: 3.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side Effect Electrode with Integrate

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Dec 19, 2008 after 99 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963783 (1996). 8 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K974022: VAPR, Mitek Products (1998) Summary page 2.
- K000936: Vapr 2.3MM Wedge Electrode for Use with Vapr System, Mitek Products (2000) Summary page 2.
- K992876: Vapr 2.3 MM Side Effect Electrode for Use with Vapr System, Mitek Products (1999) Summary page 2.
- K992406: Vapr 2.3MM End Effect Electrode for Use with Vapr System, Mitek Products (1999) Summary page 3.
- K002402: Vapr TC Electrode for Use with Vapr II Electrosurgical System, Mitek Products (2000) Summary page 3.

## Most influential descendants
- K100638: Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214 (2010), 8 descendants of its own
- K152777: Bovie Disposable Bipolar Ablator (2016), 3 descendants of its own
- K161558: Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating,  Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating (2016), 2 descendants of its own
- K231126: Eblator Device (2023), 1 descendant of its own
- K251899: E Blator (2025), 0 descendants of its own

## Recalls of this device
- Mar 12, 2012 · Class II · Z-0133-2013: Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode
- Jun 7, 2010 · Not classified · Z-2301-2010: Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility

## Indications for use
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9° and S° ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. The VAPR TC Electrode with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, is intended for coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

Source page: https://510kreport.com/device/K082643
Methodology: https://510kreport.com/methodology