HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length— 510(k) K191555

Substantially Equivalent

Ethicon Endo-Surgery, LLC

FDA 510(k) clearance K191555 for HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length, Substantially Equivalent on 2020-02-28. Applicant: Ethicon Endo-Surgery, LLC.

Clearance details

Applicant: Ethicon Endo-Surgery, LLC
Product code: Code LFL
Advisory panel: Unknown
Date received: 2019-06-12
Decision date: 2020-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
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.