UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F— 510(k) K993647

Substantially Equivalent

Unimed Surgical Products, Inc.

FDA 510(k) clearance K993647 for UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F, Substantially Equivalent on 1999-11-16. Applicant: Unimed Surgical Products, Inc..

Clearance details

Applicant: Unimed Surgical Products, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1999-10-29
Decision date: 1999-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Largo, FL, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.