3M MINI-DRIVER ELECTRIC SYSTEM— 510(k) K955098

Substantially Equivalent

3M Company

FDA 510(k) clearance K955098 for 3M MINI-DRIVER ELECTRIC SYSTEM, Substantially Equivalent on 1996-01-22. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code HWE
Advisory panel: General, Plastic Surgery
Date received: 1995-11-07
Decision date: 1996-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code HWE

product code HWE

Death: 4
Injury: 448
Malfunction: 19,856
Other: 2
Total: 20,310

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.