TRT (ACUSON) NEEDLE GUIDE KIT, STERILE— 510(k) K892068

Substantially Equivalent

Amedic USA

FDA 510(k) clearance K892068 for TRT (ACUSON) NEEDLE GUIDE KIT, STERILE, Substantially Equivalent on 1989-08-04. Applicant: Amedic USA.

Clearance details

Applicant: Amedic USA
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-30
Decision date: 1989-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.