SHORT PORT BLUNT TIP TROCAR— 510(k) K130121

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K130121 for SHORT PORT BLUNT TIP TROCAR, Substantially Equivalent on 2013-04-11. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2013-01-17
Decision date: 2013-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

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.