BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR— 510(k) K133375

Substantially Equivalent

Banyan Medical, LLC

FDA 510(k) clearance K133375 for BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR, Substantially Equivalent on 2014-01-17. Applicant: Banyan Medical, LLC.

Clearance details

Applicant: Banyan Medical, LLC
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2013-11-04
Decision date: 2014-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warwick, RI, 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.