Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818
FDA 510(k) K081323 · B-K Medical Aps
510(k) numberK081323
Submission
- Device name
- Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818
- Applicant
- B-K Medical Aps
Herlev, DK - Received
- May 12, 2008
- Decision date
- July 22, 2008
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K140428 | Ultrasound Scanner System BK2300IYO · Abbreviated | 05/30/2014SE |
| K132346 | Ultrasound Scanner Pro Focus 2202IYO · Traditional | 01/10/2014SE |
| K132335 | Ultrasound Scanner Flex Focus 1202IYN · Traditional | 01/10/2014SE |
| K132677 | Ultrasound Scanner Flex Focus 1202IYN · Traditional | 01/07/2014SE |
| K132685 | Ultrasound Scanner Pro Focus 2202IYN · Traditional | 01/06/2014SE |
| K123254 | Ultrasound Scanner Flex FocusIYN · Traditional | 02/13/2013SE |
| K100919 | Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202IYN · Traditional | 12/16/2011SE |
| K083667 | Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model Ua 1336, Needle Guide…ITX · Traditional | 02/02/2009SE |
| K081154 | Ultrasound Scanner Flex Focus, Model 1202IYO · Special | 05/23/2008SE |
| K070077 | Ultrasound Scanner Profocus, Model 2202IYO · Traditional | 03/05/2007SE |
Questions and answers
When was Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818 cleared by the FDA?
Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818 (K081323) received a 510(k) decision of Substantially Equivalent on July 22, 2008, 71 days after the submission was received.
What is the product code of K081323?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.