3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160)— 510(k) K971446

Substantially Equivalent

3M Company

FDA 510(k) clearance K971446 for 3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160), Substantially Equivalent on 1997-07-18. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1997-04-21
Decision date: 1997-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.