SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)— 510(k) K012456
Substantially EquivalentSodemsystems
FDA 510(k) clearance K012456 for SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT), Substantially Equivalent on 2001-09-21. 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- 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)
- 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.