# K141484: Open Fmsealer

- Pathway: 510(k) (Traditional)
- Applicant: Domain Surgical, Inc.
- Decided: Jul 30, 2014 after 55 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K933157 (1994). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 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.
- K043273: Ligasure Vessel Sealing System. Ligasure Instruments, Valleylab (2005) Summary page 1.

## Most influential descendants
- K142229: Laparoscopic FMsealer (2015), 0 descendants of its own

## Recalls of this device
- Oct 24, 2016 · Class II · Z-0690-2017: Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.

## Indications for use
The Open FMsealer is intended for use in general and gynecological surgery and other open surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of heat (coagulation) to vessels interposed between the jaws of the device. The Open FMsealer can be used to seal and ligate vessels up to 7mm and tissue bundles as large as will fit in the jaws of the Instrument. The Open 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/K141484
Methodology: https://510kreport.com/methodology