# K142229: Laparoscopic FMsealer

- Pathway: 510(k) (Traditional)
- Applicant: Domain Surgical, Inc.
- Decided: Jan 2, 2015 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
Longest line of descent: 7 generations back to K933157 (1994). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043273: Ligasure Vessel Sealing System. Ligasure Instruments, Valleylab (2005) Summary page 4.
- K141484: Open Fmsealer, Domain Surgical, Inc. (2014) Summary page 4.

## Indications for use
The Laparoscopic FMsealer is an electrosurgical instrument intended for use in open and laparoscopic surgical procedures, including general and gynecologic procedures where ligation and division of vessels, including lymph vessels, is desired. It can be used to ligate and divide vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instrument. The Laparoscopic FMsealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these purposes.

Source page: https://510kreport.com/device/K142229
Methodology: https://510kreport.com/methodology