Spinocan Spinal Needle
FDA 510(k) K820047 · Burron Medical Products, Inc.
510(k) numberK820047
Submission
- Device name
- Spinocan Spinal Needle
- Applicant
- Burron Medical Products, Inc.
Mchenry, IL, US - Received
- January 8, 1982
- Decision date
- January 25, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K870403 | Cavafix(R) Central Venous Catheter Kit W/SutureFOZ · Traditional | 05/01/1987SE |
| K862412 | IntestoplantLLD · Traditional | 11/13/1986SE |
| K861479 | Cavafix, Central Venous Catheter KitFOZ · Traditional | 07/01/1986SESD |
| K860126 | Stimuplex, Nerve StimulatorBXN · Traditional | 02/28/1986SE |
| K851293 | ImplantofixLJT · Traditional | 01/09/1986SE |
| K841428 | Jejunostomy Set for Tube FeedingKNT · Traditional | 07/09/1984SE |
| K834383 | Dual-Lumen Long Term Central Venous CatLJS · Traditional | 05/01/1984SE |
| K834299 | Long Term Central Venous Access CathLJS · Traditional | 05/01/1984SE |
| K834473 | Multi-Lumen Central Venous Cath. KitLJS · Traditional | 04/30/1984SE |
| K840179 | Continuous Epidural Anesthes. TrayCAZ · Traditional | 02/24/1984SE |
Questions and answers
When was Spinocan Spinal Needle cleared by the FDA?
Spinocan Spinal Needle (K820047) received a 510(k) decision of Substantially Equivalent on January 25, 1982, 17 days after the submission was received.
What is the product code of K820047?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.