ADMS BIOPSY NEEDLE— 510(k) K890203

Name: FDA 510(k) clearance K890203
Creator: U.S. Food and Drug Administration
Published: 1989-03-08

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.. Device class: 2.

Clearance details

Applicant: Advanced Diagnostic Medical Systems, Inc.
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
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 ↗

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More clearances from Advanced Diagnostic Medical Systems, Inc.

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K882746 — ADMS SILENT NEEDLE GUN1989-03-17
K881208 — PROBE SHEATH FOR ADMS ULTRASOUND PROBE1988-05-16
K875119 — BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE1988-03-02

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.