ALLEN, ULTRA AND SMART SOCKETS— 510(k) K971988

Name: FDA 510(k) clearance K971988
Creator: U.S. Food and Drug Administration
Published: 1997-07-11

Substantially Equivalent

Allen Medical Systems, Inc.

FDA 510(k) clearance K971988 for ALLEN, ULTRA AND SMART SOCKETS, Substantially Equivalent on 1997-07-11. Applicant: Allen Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Allen Medical Systems, Inc.
Product code: Code FQO
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1997-05-29
Decision date: 1997-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FQO

product code FQO

Death: 6
Injury: 145
Malfunction: 685
Total: 836

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.