ADMS BIOPSY NEEDLE— 510(k) K890203

Substantially Equivalent

Advanced Diagnostic Medical Systems, Inc.

FDA 510(k) clearance K890203 for ADMS BIOPSY NEEDLE, Substantially Equivalent on 1989-03-08. Applicant: Advanced Diagnostic Medical Systems, Inc..

Clearance details

Applicant: Advanced Diagnostic Medical Systems, Inc.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 1989-01-17
Decision date: 1989-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

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.