ELECTROSURGICAL GENERATOR MODEL ESU100/250/550— 510(k) K914367

Substantially Equivalent

Gyne-Tech Instrument Corp.

FDA 510(k) clearance K914367 for ELECTROSURGICAL GENERATOR MODEL ESU100/250/550, Substantially Equivalent on 1992-04-28. Applicant: Gyne-Tech Instrument Corp..

Clearance details

Applicant: Gyne-Tech Instrument Corp.
Product code: Code HGI
Advisory panel: Obstetrics/Gynecology
Date received: 1991-10-01
Decision date: 1992-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burbank, CA, 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.