da Vinci SP SureForm 45 Staplers and Reloads (SP1098)— 510(k) K243596

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K243596 for da Vinci SP SureForm 45 Staplers and Reloads (SP1098), Substantially Equivalent on 2025-03-10. Applicant: Intuitive Surgical, Inc..

Clearance details

Applicant: Intuitive Surgical, Inc.
Product code: Code GAG
Advisory panel: General Hospital
Date received: 2024-11-21
Decision date: 2025-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAG

product code GAG

Death: 23
Injury: 394
Malfunction: 2,304
Other: 6
Total: 2,727

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.