ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203— 510(k) K903602

Substantially Equivalent

Dixon Medical, Inc.

FDA 510(k) clearance K903602 for ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203, Substantially Equivalent on 1990-09-12. Applicant: Dixon Medical, Inc..

Clearance details

Applicant: Dixon Medical, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1990-08-08
Decision date: 1990-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.