WILSON-COOK ULTRASOUND BIOPSY NEEDLE
FDA 510(k) clearance K013356 · decided 2001-10-19
Clearance details
- K-number
- K013356
- Device name
- WILSON-COOK ULTRASOUND BIOPSY NEEDLE
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-10
- Decision date
- 2001-10-19
- Days to decision
- 9 days
- Clearance type
- Special
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. recall (Z-0079-04) | Wilson-Cook Medical Inc | 2003-10-31 |