BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
FDA 510(k) K150891 · Covidien, LLC( Formerly Beacon Endoscopic Corp.)
510(k) numberK150891
Submission
- Device name
- BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
- Applicant
- Covidien, LLC( Formerly Beacon Endoscopic Corp.)
Mansfield, MA, US - Received
- April 2, 2015
- Decision date
- May 1, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional | Cook Ireland, Ltd. | 05/30/2023SE |
| 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 |
More from Cook Ireland, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K141894 | Sharkcore Fine Needle Biopsy SystemFCG · Traditional | 10/06/2014SE |
Questions and answers
When was BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System cleared by the FDA?
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System (K150891) received a 510(k) decision of Substantially Equivalent on May 1, 2015, 29 days after the submission was received.
What is the product code of K150891?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.