BNX FINE NEEDLE ASPIRATION SYSTEM
FDA 510(k) clearance K103668 · decided 2010-12-30
Clearance details
- K-number
- K103668
- Device name
- BNX FINE NEEDLE ASPIRATION SYSTEM
- Applicant
- Boston Endoscopic Engineering
- Decision
- Substantially Equivalent
- Date received
- 2010-12-16
- Decision date
- 2010-12-30
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Foster, RI, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01 recall (Z-1472-2017) | Medtronic | 2017-02-28 |
| SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01 recall (Z-1473-2017) | Medtronic | 2017-02-28 |
| SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01 recall (Z-1474-2017) | Medtronic | 2017-02-28 |
| SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01 recall (Z-1475-2017) | Medtronic | 2017-02-28 |
| BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01 recall (Z-1476-2017) | Medtronic | 2017-02-28 |