MICRON-SCOPE— 510(k) K853499

Name: FDA 510(k) clearance K853499
Creator: U.S. Food and Drug Administration
Published: 1985-09-24

Substantially Equivalent

Magnum Diamond, Inc.

FDA 510(k) clearance K853499 for MICRON-SCOPE, Substantially Equivalent on 1985-09-24. Applicant: Magnum Diamond, Inc.. Device class: 1.

Clearance details

Applicant: Magnum Diamond, Inc.
Product code: Code HNN
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1985-08-20
Decision date: 1985-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HNN

product code HNN

Injury: 183
Malfunction: 4,106
Total: 4,289

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.