# K120040: Reprocessed Surgical Electric Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Oct 5, 2012 after 274 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- 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: 4 generations back to K932293 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070162: Forcetriad Electrosurgical Generator; Ligasure Instruments, Valleylab,A Division of Tyco Healthcare Group LP (2007) Summary page 1.

## Indications for use
The Reprocessed Surgical Electric instrument (hereinafter sealer/divider) is indicated for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. When used with the ForceTriad T1I energy platform the sealer/divider can also be used to seal pulmonary vasculature. The sealer/divider should not be used for tubal sterilization or tubal coagulation as it has not been shown effective for sterilization procedures.

Source page: https://510kreport.com/device/K120040
Methodology: https://510kreport.com/methodology