# K113545: Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System Coolpluse 90 and Coolpluse 90 with Han

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Feb 27, 2012 after 88 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: 7 generations back to K011083 (2001). 17 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041810: Serfas Energy System, Stryker Endoscopy (2004) Summary page 3.

## Most influential descendants
- 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
- K173740: Reprocessed DePuy Mitek Ablation Wand (2018), 0 descendants of its own

## Indications for use
VAPR VUE Radiofrequency system The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery. VAPR II Electrosurgical system The Mitek VAPR II Electrode System, when used with a VAPR M Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery. VAPR III Electrosurgical system The VAPR III Electrode System, when used with a VAPR M Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery. VAPR CoolPulse Electrodes (CP90, CP90 with Handcontrol) The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist. VAPR Suction Electrodes (P90, LDS and LPS Electrode) The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

Source page: https://510kreport.com/device/K113545
Methodology: https://510kreport.com/methodology