CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE— 510(k) K923628

Substantially Equivalent

Bruce Mclucas

FDA 510(k) clearance K923628 for CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE, Substantially Equivalent on 1994-02-22. Applicant: Bruce Mclucas.

Clearance details

Applicant: Bruce Mclucas
Product code: Code HGI
Advisory panel: Obstetrics/Gynecology
Date received: 1992-07-21
Decision date: 1994-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.