# K160539: BiZact Open Sealer/Divider

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Jun 15, 2016 after 110 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: 8 generations back to K932293 (1994). 23 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152286: LigaSure Curved, Small Jaw, Open Sealer/Divider, Covidien (2015) Summary page 4.

## Most influential descendants
- K171066: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (2017), 2 descendants of its own
- K182451: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (2018), 1 descendant of its own
- K193356: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (2020), 0 descendants of its own

## Indications for use
The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The tissue fusion function of the device can be used on vessels (arteries and veins) and lymphatics up to and including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures. It is also indicated for adult ENT procedures, including tonsillectomy, for the ligation and division of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures. The BiZact device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use for these procedures.

Source page: https://510kreport.com/device/K160539
Methodology: https://510kreport.com/methodology