COAXIAL BIOPSY NEEDLE
FDA 510(k) clearance K936194 · decided 1994-03-22
Clearance details
- K-number
- K936194
- Device name
- COAXIAL BIOPSY NEEDLE
- Applicant
- Bard Gynecology and Radiology
- Decision
- Substantially Equivalent
- Date received
- 1993-12-29
- Decision date
- 1994-03-22
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Covington, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B The TruGui recall (Z-2547-2016) | Bard Peripheral Vascular Inc | 2016-08-16 |
| Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalo recall (Z-0913-06) | Bard Peripheral Vascular Inc | 2006-05-31 |