# K252487: POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Mar 2, 2026 after 207 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: 8 generations back to K932293 (1994). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162047: LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated, Covidien (2016) Summary page 6.

## Indications for use
The POWERSEAL Open Extended Jaw, Sealer & Divider, Double-Action is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. POWERSEAL Open Extended Jaw, Sealer & Divider, Double-Action instruments can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7 mm. POWERSEAL Open Extended Jaw, Sealer & Divider, Double-Action instruments are indicated for use in general surgery and such surgical specialties as urologic, colorectal, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, and oophorectomy. The POWERSEAL Open Extended Jaw has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use POWERSEAL Open Extended Jaw for these procedures.

Source page: https://510kreport.com/device/K252487
Methodology: https://510kreport.com/methodology