RETROBULBAR NEEDLE— 510(k) K873848

Name: FDA 510(k) clearance K873848
Creator: U.S. Food and Drug Administration
Published: 1987-10-23

Substantially Equivalent

Healthtek, Inc.

FDA 510(k) clearance K873848 for RETROBULBAR NEEDLE, Substantially Equivalent on 1987-10-23. Applicant: Healthtek, Inc.. Device class: 1.

Clearance details

Applicant: Healthtek, Inc.
Product code: Code GDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-09-22
Decision date: 1987-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nevada City, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDM

product code GDM

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.