SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY— 510(k) K954717

Substantially Equivalent

Sodem Diffusion SA

FDA 510(k) clearance K954717 for SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY, Substantially Equivalent on 1997-01-22. Applicant: Sodem Diffusion SA.

Clearance details

Applicant: Sodem Diffusion SA
Product code: Code HBB
Advisory panel: Neurology
Date received: 1995-10-13
Decision date: 1997-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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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.