# K193356: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Mar 2, 2020 after 89 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: 11 generations back to K932293 (1994). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182451: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider, Covidien, LLC (2018) Summary page 4.

## 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 of the device can be used on vessels (arteries and veins) and lymphatics up to an including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures. It's also indicated for adult, children and adolescent ENT procedures (3 years of age and above), 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/K193356
Methodology: https://510kreport.com/methodology