MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE— 510(k) K001293

Name: FDA 510(k) clearance K001293
Creator: U.S. Food and Drug Administration
Published: 2000-05-05

Substantially Equivalent

Medimop Medical Projects, Ltd.

FDA 510(k) clearance K001293 for MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE, Substantially Equivalent on 2000-05-05. Applicant: Medimop Medical Projects, Ltd.. Device class: 2.

Clearance details

Applicant: Medimop Medical Projects, Ltd.
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2000-04-24
Decision date: 2000-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.