RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201— 510(k) K982130

Name: FDA 510(k) clearance K982130
Creator: U.S. Food and Drug Administration
Published: 1998-08-07

Substantially Equivalent

New Deantronics, Ltd.

FDA 510(k) clearance K982130 for RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201, Substantially Equivalent on 1998-08-07. Applicant: New Deantronics, Ltd.. Device class: 2.

Clearance details

Applicant: New Deantronics, Ltd.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1998-06-17
Decision date: 1998-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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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.