EndoWrist Stapler 45 System and Stapler 45 Reloads— 510(k) K171388

Name: FDA 510(k) clearance K171388
Creator: U.S. Food and Drug Administration
Published: 2017-05-31

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K171388 for EndoWrist Stapler 45 System and Stapler 45 Reloads, Substantially Equivalent on 2017-05-31. Applicant: Intuitive Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Intuitive Surgical, Inc.
Product code: Code NAY
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2017-05-11
Decision date: 2017-05-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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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.