DeviceClearance

K243596

Substantially Equivalent

da Vinci SP SureForm 45 Staplers and Reloads (SP1098)

Applicant
Intuitive Surgical, Inc.
Product code
GAG
Advisory panel
General Hospital
Date received
Decision date
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, through . 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.