Global Medical Cutting Biopsy Needle
FDA 510(k) K934256 · Global Medical Prods, Inc.
510(k) numberK934256
Submission
- Device name
- Global Medical Cutting Biopsy Needle
- Applicant
- Global Medical Prods, Inc.
Road Town, Tortola, VG - Received
- August 31, 1993
- Decision date
- March 28, 1994
- 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 |
|---|---|---|
| K962329 | Global Loss of Resistance Syringe Glor 10FMF · Traditional | 09/12/1996SE |
| K961324 | Global Medical Products Spinal,Conical Tip (Sprottle Style), Whitacre Style NeedlesMIA · Traditional | 07/02/1996SE |
| K952275 | Global Medical Products Tuohy & Crawford Epidural Needle W/Plastic HubBSP · Traditional | 10/11/1995SE |
| K871556 | Merivaara Emergency Patient Trolley #436FPO · Traditional | 04/30/1987SE |
| K863748 | Hospital BedFNJ · Traditional | 10/09/1986SE |
| K862959 | Merivaara Patient Trolley - Model #416FPO · Traditional | 09/25/1986SE |
| K862957 | Merivaara Geriatric Chair Model 455INN · Traditional | 08/21/1986SE |
| K862931 | Merivaara Obstetric Chair/Bed-Model 358KNC · Traditional | 08/07/1986SE |
Questions and answers
When was Global Medical Cutting Biopsy Needle cleared by the FDA?
Global Medical Cutting Biopsy Needle (K934256) received a 510(k) decision of Substantially Equivalent on March 28, 1994, 209 days after the submission was received.
What is the product code of K934256?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.