EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
FDA 510(k) clearance K230909 · decided 2023-05-30
Clearance details
- K-number
- K230909
- Device name
- EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
- Applicant
- Cook Ireland, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-31
- Decision date
- 2023-05-30
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Limerick, IE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zilver® Flex® 35 Vascular Stent; Zilver® 635® Vascular Stent; Zilver® 518® Vascular Stent (P050017/S026) | Cook Ireland, Ltd. | 2026-04-14 |
| Zilver® Vena® Venous Self-Expanding Stent (P200023/S009) | Cook Ireland, Ltd. | 2026-04-14 |
| Zilver® PTX® Drug-Eluting Peripheral Stent (P100022/S045) | Cook Ireland, Ltd. | 2026-03-25 |
| Zilver Flex® 35 Vascular Stent (P050017/S025) | Cook Ireland, Ltd. | 2025-10-22 |
| Zilver® PTX® Peripheral Drug-Eluting Stent (P100022/S044) | Cook Ireland, Ltd. | 2025-07-03 |
| Zilver Flex(R) 35 Vascular Stent (P050017/S024) | Cook Ireland, Ltd. | 2025-07-01 |
| Zilver PTX Peripheral Drug-Eluting Stent (P100022/S043) | Cook Ireland, Ltd. | 2024-12-20 |
| Zilver® Vascular Stent (P050017/S023) | Cook Ireland, Ltd. | 2024-05-14 |