# K170188: Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical Corporation
- Decided: Mar 8, 2017 after 44 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894762 (1989). 20 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112233: Bovie J-Plasma Handpiece with Retractable Cutting Blade, Bovie Medical Corporation (2012) Summary page 4.
- K151325: Bovie J-Plasma Handpiece, Bovie Medical Corporation (2015) Summary page 4.
- K152570: Bovie J-Plasma Precise 360 Handpiece, Bovie Medical Corporation (2015) Summary page 4.
- K142975: Bovie Ultimate High Frequency Electrosurgical Generator, Bovie Medical Corporation (2014) Summary page 4.

## Most influential descendants
- K183610: Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces (2019), 6 descendants of its own
- K191542: Apyx Plasma/RF Handpiece (2019), 4 descendants of its own
- K220970: Renuvion APR Handpiece (2022), 3 descendants of its own
- K223262: Renuvion® APR Handpiece (2023), 2 descendants of its own
- K230272: Renuvion® APR Handpiece (2023), 1 descendant of its own

## Recalls of this device
- Apr 20, 2020 · Class II · Z-2060-2020: Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
- Feb 8, 2018 · Class II · Z-1153-2018: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists
- Feb 8, 2018 · Class II · Z-1154-2018: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists
- Feb 8, 2018 · Class II · Z-1157-2018: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists
- Feb 8, 2018 · Class II · Z-1156-2018: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists
- Feb 8, 2018 · Class II · Z-1155-2018: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists

## Indications for use
The Bovie Ultimate® Electrosurgical Generators are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparascopic surgical procedures. The J-plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces. The Bovie J-Plasma Precise Open® Handpiece is intended to be used in conjunction with the Bovie Ultimate® electrosurgical generator for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The Bovie J-Plasma Precise Open® Handpiece is compatible with Bovie Ultimate® Electrosurgical Generators BVX-200H, and BVX-200P.

Source page: https://510kreport.com/device/K170188
Methodology: https://510kreport.com/methodology