TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER— 510(k) K000665

Name: FDA 510(k) clearance K000665
Creator: U.S. Food and Drug Administration
Published: 2000-05-02

Substantially Equivalent

Tfx Medical, Inc.

FDA 510(k) clearance K000665 for TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, Substantially Equivalent on 2000-05-02. Applicant: Tfx Medical, Inc.. Device class: 2.

Clearance details

Applicant: Tfx Medical, Inc.
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2000-02-28
Decision date: 2000-05-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Jeffrey, NH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Tfx Medical, Inc.

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K021034 — MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER2002-06-26
K020985 — MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER2002-06-25
K993191 — TFX MEDICAL INTRODUCER ASSEMBLY2000-03-24

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.