SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION— 510(k) K914329

Name: FDA 510(k) clearance K914329
Creator: U.S. Food and Drug Administration
Published: 1992-04-02

Substantially Equivalent

Ellman Intl. Mfg., Inc.

FDA 510(k) clearance K914329 for SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION, Substantially Equivalent on 1992-04-02. Applicant: Ellman Intl. Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Ellman Intl. Mfg., Inc.
Product code: Code HGI
Device class: Class 2
Regulation: 21 CFR 884.4120
Advisory panel: Obstetrics/Gynecology
Date received: 1991-09-27
Decision date: 1992-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Jefferson, NY, 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.