EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
FDA 510(k) clearance K210476 · decided 2021-05-20
Clearance details
- K-number
- K210476
- Device name
- EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
- Applicant
- Cook Ireland, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-19
- Decision date
- 2021-05-20
- Days to decision
- 90 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.
| Record | Firm | Date |
|---|---|---|
| Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (K252646) | Olympus Medical Systems Corp. | 2025-10-24 |
| ClearTip FNA and FNB Types (K250994) | Finemedix Co., Ltd. | 2025-08-21 |
| EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (K241209) | Cook Ireland, Ltd. | 2024-07-29 |
| Precision GI (K231422) | Limaca Medical, Ltd. | 2023-08-28 |
| ClearTip (K231267) | Finemedix Co., Ltd. | 2023-06-30 |
| EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (K230909) | Cook Ireland, Ltd. | 2023-05-30 |
| EndoDrill® Model X (K212423) | Bibbinstruments AB | 2023-03-29 |
| Disposable Biopsy Refill Needle (K212819) | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| Disposable Coaxial Biopsy Needle (K212822) | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| Biopsy Needle (K191472) | Ushare Medical, Inc. | 2020-01-29 |
| Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle (K181756) | Apriomed AB | 2018-12-18 |
| Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N (K180668) | Olympus Medical Systems Corp. | 2018-11-15 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 recall (Z-1833-2024) | Cook Medical Incorporated | 2024-05-16 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| Zilver Vena® Venous Self-Expanding Stent (P200023/S008) | Cook Ireland, Ltd. | 2024-05-14 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S007) | Cook Ireland, Ltd. | 2024-02-08 |
| Zilver® PTX® Peripheral Drug- Eluting Stent (P100022/S042) | Cook Ireland, Ltd. | 2023-09-22 |