5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT— 510(k) K112584

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K112584 for 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT, Substantially Equivalent on 2011-09-29. Applicant: Intuitive Surgical, Inc..

Clearance details

Applicant: Intuitive Surgical, Inc.
Product code: Code NAY
Advisory panel: Gastroenterology, Urology
Date received: 2011-09-06
Decision date: 2011-09-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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Adverse events under product code NAY

product code NAY

Death: 433
Injury: 7,927
Malfunction: 93,790
Other: 19
Total: 102,169

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.