Automated Core Biopsy Device
FDA 510(k) K011270 · Promex, Inc.
510(k) numberK011270
Submission
- Device name
- Automated Core Biopsy Device
- Applicant
- Promex, Inc.
Franklin, IN, US - Received
- April 26, 2001
- Decision date
- June 22, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K023450 | Biopsy Site Tissue Marker DeviceNEU · Traditional | 12/19/2002SE |
| K022634 | Co-Axial Introducer NeedleDYB · Traditional | 11/06/2002SE |
| K010400 | Vacuum Assisted Core Biopsy DeviceKNW · Traditional | 07/24/2001SE |
| K001132 | Bone Biopsy NeedleKNW · Traditional | 05/01/2000SE |
| K994272 | Automated Core Biopsy DeviceKNW · Traditional | 01/07/2000SE |
| K993435 | Manual Bone Marrow Biopsy DeviceKNW · Traditional | 12/06/1999SE |
| K973184 | Prostate Seeding NeedleIWJ · Traditional | 11/21/1997SE |
| K972865 | Promex ENT Tissue Removal SystemERL · Traditional | 09/29/1997SE |
| K961078 | Automated Vitrectomy DeviceHQE · Traditional | 06/14/1996SE |
| K960023 | Kirshner Wires (K-Wire) & Steinmann PinsJDW · Traditional | 03/18/1996SE |
Questions and answers
When was Automated Core Biopsy Device cleared by the FDA?
Automated Core Biopsy Device (K011270) received a 510(k) decision of Substantially Equivalent on June 22, 2001, 57 days after the submission was received.
What is the product code of K011270?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.