Biopsy Needle Guide Kit, Sterile
FDA 510(k) K871467 · Amedic USA
510(k) numberK871467
Submission
- Device name
- Biopsy Needle Guide Kit, Sterile
- Applicant
- Amedic USA
Phoenix, AZ, US - Received
- April 14, 1987
- Decision date
- August 21, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K897120 | Equip Covers, SterileKKX · Traditional | 01/04/1990SE |
| K892070 | General Ivt Needle Guide Kit, SterileHGL · Traditional | 09/05/1989SE |
| K892071 | General (Biopsy) Needle Guide Kit, SterileKNW · Traditional | 08/08/1989SE |
| K892069 | Extended Covers, SterileFFF · Traditional | 08/08/1989SE |
| K892068 | TRT (Acuson) Needle Guide Kit, SterileFCG · Traditional | 08/04/1989SE |
| K871609 | Ultrasound Transducer Sheaths, SterileITX · Traditional | 07/15/1987SE |
| K871565 | Ultrasound Transducer Gel, SterileJOT · Traditional | 07/15/1987SE |
| K871503 | Biopsy Needle Guide Kit, SterileFZX · Traditional | 07/10/1987SE |
| K864219 | Transvaginal Ultrasound Biopsy Needle GuideHGL · Traditional | 03/27/1987SE |
Questions and answers
When was Biopsy Needle Guide Kit, Sterile cleared by the FDA?
Biopsy Needle Guide Kit, Sterile (K871467) received a 510(k) decision of Substantially Equivalent on August 21, 1987, 129 days after the submission was received.
What is the product code of K871467?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.