FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE— 510(k) K800406

Name: FDA 510(k) clearance K800406
Creator: U.S. Food and Drug Administration
Published: 1980-03-12

Substantially Equivalent

A.D.T. Lab Industries

FDA 510(k) clearance K800406 for FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE, Substantially Equivalent on 1980-03-12. Applicant: A.D.T. Lab Industries. Device class: 1.

Clearance details

Applicant: A.D.T. Lab Industries
Product code: Code GDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1980-02-26
Decision date: 1980-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K953082 — ILIAC CREST BONE MARROW ASPIRATION NEEDLE1995-09-22
K953064 — BIOACCESS MARROW HARVEST SYSTEM1995-08-07
K936207 — ENDO-NEEDLE INSTRUMENT1994-06-16

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K812297 — A.D.T. PROCEDURES TRAY1981-09-28
K801753 — ADT BONE MARROW BIOPSY-ASPIR. NEELDE1980-08-20
K801754 — ADT BONE MARROW ASPIRATION NEEDLE1980-08-20
K800408 — ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE1980-04-28
K800409 — ADT BONE MARROW BIOPSY ASPIRATION TRAY1980-04-28

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.