SINGLE-SITE PORT— 510(k) K133203

Unknown

Intuitive Surgical, Inc.

FDA 510(k) clearance K133203 for SINGLE-SITE PORT, Unknown on 2014-05-09. Applicant: Intuitive Surgical, Inc..

Clearance details

Applicant: Intuitive Surgical, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2013-10-17
Decision date: 2014-05-09
Decision: Unknown
Clearance type: Traditional
Location: Sunnyvale, CA, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.