MODEL GT1ST CRYOSURGICAL INSTRUMENT— 510(k) K922878

Substantially Equivalent

Gyne-Tech Instrument Corp.

FDA 510(k) clearance K922878 for MODEL GT1ST CRYOSURGICAL INSTRUMENT, Substantially Equivalent on 1992-09-02. Applicant: Gyne-Tech Instrument Corp..

Clearance details

Applicant: Gyne-Tech Instrument Corp.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 1992-06-15
Decision date: 1992-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burbank, CA, US

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Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.