DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES— 510(k) K993777

Name: FDA 510(k) clearance K993777
Creator: U.S. Food and Drug Administration
Published: 2000-05-25

Substantially Equivalent

R-Group Intl.

FDA 510(k) clearance K993777 for DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES, Substantially Equivalent on 2000-05-25. Applicant: R-Group Intl.. Device class: 2.

Clearance details

Applicant: R-Group Intl.
Product code: Code HGI
Device class: Class 2
Regulation: 21 CFR 884.4120
Advisory panel: Obstetrics/Gynecology
Date received: 1999-11-08
Decision date: 2000-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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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.