EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
FDA 510(k) K230909 · Cook Ireland, Ltd.
510(k) numberK230909
Submission
- Device name
- EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
- Applicant
- Cook Ireland, Ltd.
Limerick, IE - Received
- March 31, 2023
- Decision date
- May 30, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCG – Biopsy Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)FCG · Traditional | Olympus Medical Systems Corp. | 10/24/2025SE |
| K250994 | ClearTip FNA and FNB TypesFCG · Traditional | Finemedix Co., Ltd. | 08/21/2025SE |
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional | Cook Ireland, Ltd. | 07/29/2024SE |
| K231422 | Precision GIFCG · Traditional | Limaca Medical, Ltd. | 08/28/2023SE |
| K231267 | ClearTipFCG · Traditional | Finemedix Co., Ltd. | 06/30/2023SE |
| K212423 | EndoDrill® Model XFCG · Traditional | Bibbinstruments AB | 03/29/2023SE |
| K212822 | Disposable Coaxial Biopsy NeedleFCG · Traditional | Suzhou Leapmed Healthcare Corporation | 07/06/2022SE |
| K212819 | Disposable Biopsy Refill NeedleFCG · Traditional | Suzhou Leapmed Healthcare Corporation | 07/06/2022SE |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional | Cook Ireland, Ltd. | 05/20/2021SE |
| K191472 | Biopsy NeedleFCG · Traditional | Ushare Medical, Inc. | 01/29/2020SE |
More from Ushare Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…KTI · Traditional | 07/24/2026SE |
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional | 07/29/2024SE |
| K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen®…FGE · Traditional | 06/14/2024SE |
| K213946 | Compass BDS Biliary StentFGE · Traditional | 05/09/2022SE |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional | 05/20/2021SE |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary StentFGE · Special | 11/16/2018SESU |
| K180868 | Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary…FGE · Traditional | 07/06/2018SE |
| K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing…FGE · Traditional | 03/09/2018SE |
| K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary…FGE · Traditional | 02/27/2018SE |
| K171619 | 14Fr Colon Decompression Set, Macon Colon Decompression SetFEG · Traditional | 08/01/2017SE |
Questions and answers
When was EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) cleared by the FDA?
EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) (K230909) received a 510(k) decision of Substantially Equivalent on May 30, 2023, 60 days after the submission was received.
What is the product code of K230909?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.