# K140384: Fmwand Handpiece SE

- Pathway: 510(k) (Traditional)
- Applicant: Domain Surgical, Inc.
- Decided: May 23, 2014 after 98 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: 6 generations back to K933157 (1994). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130606: Fmwand Ferromagnetic Surgical System, Domain Surgical, Inc. (2014) Summary page 1.
- K120454: Safeair Smoke Pencil,, Lna Medical Aps (2012) Summary page 1.

## Indications for use
The FMwand Handpiece SE is indicated for cutting and coagulation of soft tissue during surgical procedures, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Source page: https://510kreport.com/device/K140384
Methodology: https://510kreport.com/methodology