ACUFEX UNIVERSAL LEG HOLDER— 510(k) K830707

Name: FDA 510(k) clearance K830707
Creator: U.S. Food and Drug Administration
Published: 1983-05-02

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K830707 for ACUFEX UNIVERSAL LEG HOLDER, Substantially Equivalent on 1983-05-02. Applicant: Acufex Microsurgical, Inc.. Device class: 1.

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code FWZ
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1983-03-07
Decision date: 1983-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K954246 — ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW1996-02-15
K952535 — ACUFEX ENDOBUTTON TAPE1996-02-08
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Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.