SODEM HIGH SPEED SYSTEM (PNEUMATIC)— 510(k) K023070
Substantially EquivalentSodemsystems
FDA 510(k) clearance K023070 for SODEM HIGH SPEED SYSTEM (PNEUMATIC), Substantially Equivalent on 2003-01-28. Applicant: Sodemsystems. Device class: 2.
Clearance details
- Applicant
- Sodemsystems
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Geneva, CH
Recent devices under product code ERL
view allMore clearances from Sodemsystems
view all- 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)
- K993851 — SODEM PERFORATOR DRIVE
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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.