HARMONIC Focus Long Shears + Adaptive Tissue Technology— 510(k) K151340

Substantially Equivalent

Ethicon Endo-Surgery, LLC

FDA 510(k) clearance K151340 for HARMONIC Focus Long Shears + Adaptive Tissue Technology, Substantially Equivalent on 2015-07-10. Applicant: Ethicon Endo-Surgery, LLC.

Clearance details

Applicant: Ethicon Endo-Surgery, LLC
Product code: Code LFL
Advisory panel: Unknown
Date received: 2015-05-19
Decision date: 2015-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Guaynabo, PR, US

Download summary PDF View on FDA.gov ↗

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.