# K020585: Zip Open Forceps with Electrosurgical Cut

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Medical, Inc.
- Decided: Jul 13, 2002 after 141 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: 1 generation back to K904993 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000496: Evershears Bipolar Scissors, Everest Medical Corp. (2000) Summary page 1.
- K904993: Laparoscopic Electrosurgical Device, Everest Medical Corp. (1991) Summary page 1.

## Recalls of this device
- May 15, 2006 · Not classified · Z-1175-06: Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of s

## Indications for use
Dissection, grasping, electrosurgical cutting, and electrosurgical coagulation to control bleeding of tissue during open surgical procedures and in general surgery.

Source page: https://510kreport.com/device/K020585
Methodology: https://510kreport.com/methodology