Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene Needles
FDA 510(k) K951421 · Global Medical Products, Ltd.
510(k) numberK951421
Submission
- Device name
- Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene Needles
- Applicant
- Global Medical Products, Ltd.
Clearwater, FL, US - Received
- March 28, 1995
- Decision date
- November 16, 1995
- 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
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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 |
|---|---|---|
| K970916 | H.V. Pulse Lavage (L31 Series)FQH · Traditional | 06/20/1997SE |
| K962821 | Epidural Anesthesia Kit and Combined Spinal Epidural Anesthesia KitCAZ · Traditional | 11/13/1996SESK |
| K961444 | Global Medical Combined Spinal Epidural Kit (Gma 1827 and Gma 1725)BSP · Traditional | 08/01/1996SE |
| K951448 | Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single…DRC · Traditional | 03/27/1996SE |
| K950311 | Global Medical Products Brest Lesion Localization Needle with Stiffened WireGDF · Traditional | 05/26/1995SE |
Questions and answers
When was Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene Needles cleared by the FDA?
Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene Needles (K951421) received a 510(k) decision of Substantially Equivalent on November 16, 1995, 233 days after the submission was received.
What is the product code of K951421?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.