DAVOL EMS ADAPTER, CAT. NO. 13-7664— 510(k) K800317

Substantially Equivalent

Electrocaine Medical System

FDA 510(k) clearance K800317 for DAVOL EMS ADAPTER, CAT. NO. 13-7664, Substantially Equivalent on 1980-03-12. Applicant: Electrocaine Medical System.

Clearance details

Applicant: Electrocaine Medical System
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1980-02-12
Decision date: 1980-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.