INCL II ENDOSCOPE— 510(k) K963642

Substantially Equivalent

Sofamor Danek USA,Inc.

FDA 510(k) clearance K963642 for INCL II ENDOSCOPE, Substantially Equivalent on 1998-03-18. Applicant: Sofamor Danek USA,Inc..

Clearance details

Applicant: Sofamor Danek USA,Inc.
Product code: Code GWG
Advisory panel: Neurology
Date received: 1996-09-12
Decision date: 1998-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.