LEEP AND LLETZ ELECTRODES— 510(k) K930132

Substantially Equivalent

Nordex Medical Corp.

FDA 510(k) clearance K930132 for LEEP AND LLETZ ELECTRODES, Substantially Equivalent on 1994-05-04. Applicant: Nordex Medical Corp..

Clearance details

Applicant: Nordex Medical Corp.
Product code: Code HGI
Advisory panel: Obstetrics/Gynecology
Date received: 1993-01-12
Decision date: 1994-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

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Adverse events under product code HGI

product code HGI

Other: 1
Total: 1

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.