ELECTROSURGICAL UNIT 3001-3009— 510(k) K781810

Name: FDA 510(k) clearance K781810
Creator: U.S. Food and Drug Administration
Published: 1978-12-20

Substantially Equivalent

Neomed Corp.

FDA 510(k) clearance K781810 for ELECTROSURGICAL UNIT 3001-3009, Substantially Equivalent on 1978-12-20. Applicant: Neomed Corp.. Device class: 2.

Clearance details

Applicant: Neomed Corp.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1978-10-26
Decision date: 1978-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEI

view all

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

More clearances from Neomed Corp.

view all

K790043 — TRACOR, CANNULA, BICEPTS BIPOLAR1979-02-08
K780118 — ELECTRODE, DISPERSIVE, DISP. NEOPAD1978-02-23

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 →

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