STEIGER TUNNELING INSTRUMENT 285— 510(k) K840529

Name: FDA 510(k) clearance K840529
Creator: U.S. Food and Drug Administration
Published: 1984-03-12

Substantially Equivalent

Evermed, Inc.

FDA 510(k) clearance K840529 for STEIGER TUNNELING INSTRUMENT 285, Substantially Equivalent on 1984-03-12. Applicant: Evermed, Inc.. Device class: 2.

Clearance details

Applicant: Evermed, Inc.
Product code: Code DRC
Device class: Class 2
Regulation: 21 CFR 870.1390
Advisory panel: Cardiovascular
Date received: 1984-02-08
Decision date: 1984-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.