3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)— 510(k) K974553

Substantially Equivalent

3M Healthcare

FDA 510(k) clearance K974553 for 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130), Substantially Equivalent on 1998-02-03. Applicant: 3M Healthcare.

Clearance details

Applicant: 3M Healthcare
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1997-11-17
Decision date: 1998-02-03
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.