ULNAR NERVE PROTECTOR— 510(k) K840421

Name: FDA 510(k) clearance K840421
Creator: U.S. Food and Drug Administration
Published: 1984-03-12

Substantially Equivalent

Devon Industries, Inc.

FDA 510(k) clearance K840421 for ULNAR NERVE PROTECTOR, Substantially Equivalent on 1984-03-12. Applicant: Devon Industries, Inc.. Device class: 1.

Clearance details

Applicant: Devon Industries, Inc.
Product code: Code FWZ
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1984-01-31
Decision date: 1984-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K943892 — POINT OF USE SHARPS A GATOR1994-12-02
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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.