GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE— 510(k) K924501

Name: FDA 510(k) clearance K924501
Creator: U.S. Food and Drug Administration
Published: 1993-04-20

Substantially Equivalent

Symbiosis Corp.

FDA 510(k) clearance K924501 for GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE, Substantially Equivalent on 1993-04-20. Applicant: Symbiosis Corp.. Device class: 1.

Clearance details

Applicant: Symbiosis Corp.
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1992-09-04
Decision date: 1993-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.