K211273

Substantially Equivalent

Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray

Applicant: Ethicon Endo-Surgery, LLC
Product code: LFL
Advisory panel: Unknown
Date received: 2021-04-27
Decision date: 2021-05-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Guaynabo, PR, US

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.