SODEM POWER SYSTEM— 510(k) K935567
Substantially EquivalentSodemsystems
FDA 510(k) clearance K935567 for SODEM POWER SYSTEM, Substantially Equivalent on 1994-01-21. Applicant: Sodemsystems. Device class: 1.
Clearance details
- Applicant
- Sodemsystems
- Product code
- Code HWE
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code HWE
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 HWE
product code HWE- Death
- 4
- Injury
- 448
- Malfunction
- 19,856
- Other
- 2
- Total
- 20,310
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.