# K152134: Reprocessed Vessel Sealer

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jan 15, 2016 after 168 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: 6 generations back to K932293 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133338: Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX), Covidien, Formerly Valleylab, A Division of Tyco H (2013) Summary page 6.

## Indications for use
The reprocessed vessel sealer/dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. Indications for use include general open and minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. 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. The reprocessed vessel sealer/dividers can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

Source page: https://510kreport.com/device/K152134
Methodology: https://510kreport.com/methodology