# K111600: Reprocessed Hand Activate Sealer/Divider

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Nov 15, 2011 after 160 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 Hand Activated Sealer/Divider can be used during open procedures to seal vessels up to and including 7mm, lymphatics and tissue bundles. The Hand Activated Sealer/Divider can also be used to seal pulmonary vasculature but only when used with the ForceTriad TM energy platform. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Source page: https://510kreport.com/device/K111600
Methodology: https://510kreport.com/methodology