PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT— 510(k) K010824

Substantially Equivalent

Science Incorporated

FDA 510(k) clearance K010824 for PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT, Substantially Equivalent on 2001-06-05. Applicant: Science Incorporated.

Clearance details

Applicant: Science Incorporated
Product code: Code MEB
Advisory panel: General Hospital
Date received: 2001-03-19
Decision date: 2001-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

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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.