HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH— 510(k) K062000

Substantially Equivalent

Ethicon Endo-Surgery, Inc.

FDA 510(k) clearance K062000 for HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH, Substantially Equivalent on 2006-09-25. Applicant: Ethicon Endo-Surgery, Inc..

Clearance details

Applicant: Ethicon Endo-Surgery, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2006-07-17
Decision date: 2006-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

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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.