EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS— 510(k) K031080

Clearance details

Applicant

Gyrus Medical, Inc.

Product code

Code GEI

Device class

Class 2

Regulation

21 CFR 878.4400

Advisory panel

General, Plastic Surgery

Date received

2003-04-04

Decision date

2003-05-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Maple Grove, MN, US

• K254185 — Potenza Prime2026-09-11
• K262364 — Ellian Enigma RF Device2026-09-02
• K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
• K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
• K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

• K050550 — GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR2005-11-09
• K050460 — GYRUS PLASMACISION AND PLASMABLEND ELECTRODES2005-10-25
• K041999 — GYRUS PLASMA SKIN RESURFACING SYSTEM2005-03-02
• K041633 — GYRUS PLASMACISION LAPAROSCOPIC SPATULA2004-10-22
• K024286 — GYRUS OPEN FORCEPS2003-11-17

Death

133

Injury

7,585

Malfunction

35,808

Other

44

Total

43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1983-2013 — GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.Class II·Terminated·Gyrus Medical, Inc·20130724

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031080.