# K972161: Bovie Model X15

- Pathway: 510(k) (Traditional)
- Applicant: Maxxim Medical
- Decided: Jun 18, 1997 after 9 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The BOVIE Model "X15 Electrosurgical Generator is Indicated for Use in laparoscopic surgical procedures for the cutting and coagulation of human tissue. The BOVIE Model X15 can be used in conjunction with the appropriate accessories and instruments for applications in General Surgery.

Source page: https://510kreport.com/device/K972161
Methodology: https://510kreport.com/methodology