MPS ACACIA PAIN KIT— 510(k) K003476

Name: FDA 510(k) clearance K003476
Creator: U.S. Food and Drug Administration
Published: 2001-01-12

Substantially Equivalent

Mps Acacia

FDA 510(k) clearance K003476 for MPS ACACIA PAIN KIT, Substantially Equivalent on 2001-01-12. Applicant: Mps Acacia. Device class: 2.

Clearance details

Applicant: Mps Acacia
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2000-11-09
Decision date: 2001-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Mps Acacia

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K090809 — MPS ACACIA POWER INJECTABLE INFUSION SET2009-04-28
K080328 — MPS ACACIA ENTERAL FEEDING TUBE2008-05-14
K052451 — MPS ACACIA MEDFLO ELASTOMERIC PUMP2005-12-08
K052946 — MPS ACACIA NERVE BLOCK NEEDLE2005-12-08
K032934 — MPS ACACIA SAFEGUARD HUBER DEVICE2003-11-13

Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.