SODEM PERFORATOR DRIVE— 510(k) K993851
Substantially EquivalentSodemsystems
FDA 510(k) clearance K993851 for SODEM PERFORATOR DRIVE, Substantially Equivalent on 1999-12-27. 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
- Traditional
- Location
- Geneva, Switzerland, 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.