# 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

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical Corporation
- Decided: Jul 29, 2016 after 53 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K011083 (2001). 80 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120791: Ambient Turboflash 90 Ifs, Arthocare Corporation (2012) Summary page 5.
- K083306: Modification to Arthrocare Arthrowands, Arthrocare Corp. (2008) Summary page 5.
- K152777: Bovie Disposable Bipolar Ablator, Bovie Medical Corporation (2016) Summary page 5.

## Most influential descendants
- K231126: Eblator Device (2023), 1 descendant of its own
- K251899: E Blator (2025), 0 descendants of its own

## Recalls of this device
- Feb 1, 2021 · Class II · Z-1153-2021: There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
- Feb 1, 2021 · Class II · Z-1154-2021: There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
- Feb 1, 2021 · Class II · Z-1155-2021: There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

## Indications for use
This device is intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. This device is intended to be used with a standard electrosurgical generator with footswitch control and a standard return electrode connection, and the electrode is to be activated only when immersed in a conductive media such as standard saline solution.

Source page: https://510kreport.com/device/K161558
Methodology: https://510kreport.com/methodology