PKS OMNI INSTRUMENT— 510(k) K081766

Name: FDA 510(k) clearance K081766
Creator: U.S. Food and Drug Administration
Published: 2008-08-08

Substantially Equivalent

Gyrus-Acmi L.P.

FDA 510(k) clearance K081766 for PKS OMNI INSTRUMENT, Substantially Equivalent on 2008-08-08. Applicant: Gyrus-Acmi L.P.. Device class: 2.

Clearance details

Applicant: Gyrus-Acmi L.P.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2008-06-20
Decision date: 2008-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEI

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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

Adverse events under product code GEI

product code GEI

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 →

Recalls naming K081766

K-number listed on FDA's recall record

Z-2380-2021 — Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PCClass II·Terminated·Olympus Corporation of the Americas·20210609

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081766.

Data sourced from openFDA. This site is unofficial and independent of the FDA.