# K972071: Bovie Model X40

- Pathway: 510(k) (Traditional)
- Applicant: Maxxim Medical
- Decided: Oct 21, 1997 after 140 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 BOVIE Model X40 Electrosurgical Generator is Indicated for Use in laparoscopic surgical procedures for the cutting and coagulation of human tissue. The BOVIE Model X40 can be used in conjunction with the appropriate accessories and instruments for applications in: General Surgery Gynecology Urology Gastroenterology

Source page: https://510kreport.com/device/K972071
Methodology: https://510kreport.com/methodology