ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES— 510(k) K061829

Substantially Equivalent

New Leaf Medical, Inc.

FDA 510(k) clearance K061829 for ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES, Substantially Equivalent on 2006-11-17. Applicant: New Leaf Medical, Inc..

Clearance details

Applicant: New Leaf Medical, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2006-06-28
Decision date: 2006-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia Station, OH, 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.