# K061829: Electrosurgical Cutting and Coagulation Device and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: New Leaf Medical, Inc.
- Decided: Nov 17, 2006 after 142 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The BoVac Electrosurgery Suction Device removes smoke, odors, gases, particles, and fluids directly from the surgical site during electrosurgery procedures. The device is single-use and disposable.

Source page: https://510kreport.com/device/K061829
Methodology: https://510kreport.com/methodology