ADG BONE BIOPSY SYSTEM— 510(k) K890722

Name: FDA 510(k) clearance K890722
Creator: U.S. Food and Drug Administration
Published: 1989-09-21

Substantially Equivalent

American Design Group, Inc.

FDA 510(k) clearance K890722 for ADG BONE BIOPSY SYSTEM, Substantially Equivalent on 1989-09-21. Applicant: American Design Group, Inc.. Device class: 1.

Clearance details

Applicant: American Design Group, Inc.
Product code: Code GDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1989-02-13
Decision date: 1989-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDM

product code GDM

Death: 2
Total: 2

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.