AUTO-INJECTOR, SURE-INJECT 2000— 510(k) K981266

Name: FDA 510(k) clearance K981266
Creator: U.S. Food and Drug Administration
Published: 1998-07-14

Substantially Equivalent

Mighty Mo, Corp.

FDA 510(k) clearance K981266 for AUTO-INJECTOR, SURE-INJECT 2000, Substantially Equivalent on 1998-07-14. Applicant: Mighty Mo, Corp.. Device class: 2.

Clearance details

Applicant: Mighty Mo, Corp.
Product code: Code KZH
Device class: Class 2
Regulation: 21 CFR 880.6920
Advisory panel: General Hospital
Date received: 1998-04-07
Decision date: 1998-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.