SureForm 45 Curved Tip, SureForm 45 Gray Reload— 510(k) K190999

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K190999 for SureForm 45 Curved Tip, SureForm 45 Gray Reload, Substantially Equivalent on 2019-07-12. Applicant: Intuitive Surgical, Inc..

Clearance details

Applicant: Intuitive Surgical, Inc.
Product code: Code NAY
Advisory panel: Gastroenterology, Urology
Date received: 2019-04-16
Decision date: 2019-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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.