ADT DISPOSABLE THIN NEEDLE ASPIRATION— 510(k) K800418

Name: FDA 510(k) clearance K800418
Creator: U.S. Food and Drug Administration
Published: 1980-04-28

Substantially Equivalent

A.D.T. Lab Industries

FDA 510(k) clearance K800418 for ADT DISPOSABLE THIN NEEDLE ASPIRATION, Substantially Equivalent on 1980-04-28. Applicant: A.D.T. Lab Industries. Device class: 1.

Clearance details

Applicant: A.D.T. Lab Industries
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1980-02-26
Decision date: 1980-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K962328 — SINGLE USE INSTRUMENT TRAY1996-08-09
K944025 — SURGICAL INSTRUMENT TRAY1994-11-22
K912106 — ARTHROSCOPY TRAY1991-08-29
K912053 — OPEN HEART TRAY1991-08-26

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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 FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.