FIAB SPA, MODELS F7244, F7233, F7234, F7277— 510(k) K100333
Substantially EquivalentFiab Spa
FDA 510(k) clearance K100333 for FIAB SPA, MODELS F7244, F7233, F7234, F7277, Substantially Equivalent on 2010-06-21. Applicant: Fiab Spa. Device class: 2.
Clearance details
- Applicant
- Fiab Spa
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vicchio Florence, IT
Recent devices under product code GEI
view allMore clearances from Fiab Spa
view all- K192210 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
- K180047 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
- K123361 — ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
- K103783 — EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC
- K083428 — F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.