ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER
FDA 510(k) clearance K092619 · decided 2009-11-13
Clearance details
- K-number
- K092619
- Device name
- ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER
- Applicant
- Civco
- Decision
- Substantially Equivalent
- Date received
- 2009-08-26
- Decision date
- 2009-11-13
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- IYO
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kalona, IA, US
- Third-party review
- Yes
- Expedited review
- No
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