ROCKET ELECTRODE— 510(k) K974138

Substantially Equivalent

A & A Medical, Inc.

FDA 510(k) clearance K974138 for ROCKET ELECTRODE, Substantially Equivalent on 1998-01-30. Applicant: A & A Medical, Inc..

Clearance details

Applicant: A & A Medical, Inc.
Product code: Code HGI
Advisory panel: Obstetrics/Gynecology
Date received: 1997-11-03
Decision date: 1998-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, 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.