16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)— 510(k) K931338

Substantially Equivalent

Aaron Medical Industries

FDA 510(k) clearance K931338 for 16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP), Substantially Equivalent on 1994-02-16. Applicant: Aaron Medical Industries.

Clearance details

Applicant: Aaron Medical Industries
Product code: Code HGI
Advisory panel: Obstetrics/Gynecology
Date received: 1993-03-16
Decision date: 1994-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, 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.