VAPOR-TECH SLED ELECTRODE— 510(k) K970717

Substantially Equivalent

Northgate Technologies, Inc.

FDA 510(k) clearance K970717 for VAPOR-TECH SLED ELECTRODE, Substantially Equivalent on 1997-05-08. Applicant: Northgate Technologies, Inc..

Clearance details

Applicant: Northgate Technologies, Inc.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1997-02-27
Decision date: 1997-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elgin, IL, US

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Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.