GERTIE MARX NEEDLE— 510(k) K931644

Name: FDA 510(k) clearance K931644
Creator: U.S. Food and Drug Administration
Published: 1993-09-22

Substantially Equivalent

Intl. Medical-Dental Products USA, Inc.

FDA 510(k) clearance K931644 for GERTIE MARX NEEDLE, Substantially Equivalent on 1993-09-22. Applicant: Intl. Medical-Dental Products USA, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Medical-Dental Products USA, Inc.
Product code: Code BSP
Device class: Class 2
Regulation: 21 CFR 868.5150
Advisory panel: Anesthesiology
Date received: 1993-04-02
Decision date: 1993-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

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.