Global Medical Combined Spinal Epidural Kit (Gma 1827 and Gma 1725)
FDA 510(k) K961444 · Global Medical Products, Ltd.
510(k) numberK961444
Submission
- Device name
- Global Medical Combined Spinal Epidural Kit (Gma 1827 and Gma 1725)
- Applicant
- Global Medical Products, Ltd.
Woodbury, CT, US - Received
- April 15, 1996
- Decision date
- August 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BSP – Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5150
- Specialty
- Anesthesiology
Other 510(k)s with product code BSP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243690 | SonoMSKBSP · Traditional | PAJUNK GmbH Medizintechnologie | 07/01/2025SE |
| K243682 | SonoPlex STIM; SonoPlex IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 06/27/2025SE |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureBSP · Traditional | PAJUNK GmbH Medizintechnologie | 06/25/2025SE |
| K243525 | SonoTAP and SonoTAP IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 03/24/2025SE |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyBSP · Traditional | PAJUNK GmbH Medizintechnologie | 11/22/2024SE |
| K241954 | SonoBlock; SonoBlock IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 09/11/2024SE |
| K240253 | Reach NeedleBSP · Traditional | Aerin Medical, Inc. | 03/21/2024SE |
| K212982 | Medispine - Spinal Needle, Glospine - Spinal NeedleBSP · Traditional | Global Medikit Limited | 07/29/2022SE |
| K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBSP · Traditional | Becton, Dickinson and Company | 07/01/2022SE |
| K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBSP · Traditional | Becton, Dickinson and Company | 12/22/2021SE |
More from Becton, Dickinson and Company
| 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 |
| K951448 | Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single…DRC · Traditional | 03/27/1996SE |
| K951421 | Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene NeedlesFCG · Traditional | 11/16/1995SE |
| K950311 | Global Medical Products Brest Lesion Localization Needle with Stiffened WireGDF · Traditional | 05/26/1995SE |
Questions and answers
When was Global Medical Combined Spinal Epidural Kit (Gma 1827 and Gma 1725) cleared by the FDA?
Global Medical Combined Spinal Epidural Kit (Gma 1827 and Gma 1725) (K961444) received a 510(k) decision of Substantially Equivalent on August 1, 1996, 108 days after the submission was received.
What is the product code of K961444?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.