MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE— 510(k) K994175

Substantially Equivalent

Sodemsystems

FDA 510(k) clearance K994175 for MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE, Substantially Equivalent on 1999-12-21. Applicant: Sodemsystems.

Clearance details

Applicant: Sodemsystems
Product code: Code HBB
Advisory panel: Neurology
Date received: 1999-12-10
Decision date: 1999-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Geneva, CH

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Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

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.