STUCKEY STRAP-3 FINGER RESTRAINTS— 510(k) K963491

Name: FDA 510(k) clearance K963491
Creator: U.S. Food and Drug Administration
Published: 1996-11-14

Substantially Equivalent

Stuckey Ent., Inc.

FDA 510(k) clearance K963491 for STUCKEY STRAP-3 FINGER RESTRAINTS, Substantially Equivalent on 1996-11-14. Applicant: Stuckey Ent., Inc.. Device class: 1.

Clearance details

Applicant: Stuckey Ent., Inc.
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Date received: 1996-09-03
Decision date: 1996-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Corpus Christi, TX, US

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Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

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.