ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
FDA 510(k) clearance K093713 · decided 2010-01-19
Clearance details
- K-number
- K093713
- Device name
- ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
- Applicant
- Civco Medical Instruments
- Decision
- Substantially Equivalent
- Date received
- 2009-12-01
- Decision date
- 2010-01-19
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Appollo Beach, FL, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) pro recall (Z-1892-2025) | Civco Medical Instruments Co. Inc. | 2025-05-30 |
| CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs recall (Z-0286-2016) | Civco Medical Instruments Co. Inc. | 2015-11-17 |
| CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 1 recall (Z-0287-2016) | Civco Medical Instruments Co. Inc. | 2015-11-17 |
| CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18G recall (Z-0288-2016) | Civco Medical Instruments Co. Inc. | 2015-11-17 |
| CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with In recall (Z-0289-2016) | Civco Medical Instruments Co. Inc. | 2015-11-17 |
| CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in nee recall (Z-0290-2016) | Civco Medical Instruments Co. Inc. | 2015-11-17 |