BNX FINE NEEDLE ASPIRATION SYSTEM— 510(k) K103668
Substantially EquivalentBoston Endoscopic Engineering
FDA 510(k) clearance K103668 for BNX FINE NEEDLE ASPIRATION SYSTEM, Substantially Equivalent on 2010-12-30. Applicant: Boston Endoscopic Engineering. Device class: 2.
Clearance details
- Applicant
- Boston Endoscopic Engineering
- Product code
- Code FCG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster, RI, US
Recent devices under product code FCG
view allAdverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K103668
K-number listed on FDA's recall record- Z-1472-2017 — BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
- Z-1473-2017 — SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
- Z-1474-2017 — SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
- Z-1475-2017 — SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
- Z-1476-2017 — BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103668.
Data sourced from openFDA. This site is unofficial and independent of the FDA.