MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE— 510(k) K994175
Substantially EquivalentSodemsystems
FDA 510(k) clearance K994175 for MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE, Substantially Equivalent on 1999-12-21. Applicant: Sodemsystems. Device class: 2.
Clearance details
- Applicant
- Sodemsystems
- Product code
- Code HBB
- Device class
- Class 2
- Regulation
- 21 CFR 882.4370
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Geneva, CH
Recent devices under product code HBB
view allMore clearances from Sodemsystems
view all- K023070 — SODEM HIGH SPEED SYSTEM (PNEUMATIC)
- K023066 — DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
- K012453 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
- K012457 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
- K012456 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
Adverse events under product code HBB
product code HBB- Malfunction
- 2,656
- Total
- 2,656
Source: openFDA MAUDE database, through . 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.