Spinal Needle
FDA 510(k) K823692 · Ocean Medical Products, Ltd.
510(k) numberK823692
Submission
- Device name
- Spinal Needle
- Applicant
- Ocean Medical Products, Ltd.
Walker, MI, US - Received
- December 8, 1982
- Decision date
- January 7, 1983
- 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 |
|---|---|---|
| K882013 | Soft Tissue Biopsy DeviceDWO · Traditional | 06/15/1988SE |
| K870896 | Notch-Needle, Wescott StyleGAA · Traditional | 03/18/1987SE |
| K843719 | Single Wall Introducer NeedleDYB · Traditional | 10/18/1984SE |
| K823693 | Myelography NeedleFMI · Traditional | 02/07/1983SE |
| K813462 | Madayag Type NeedleKNW · Traditional | 03/01/1982SE |
| K813460 | Chiba Skinny NeedleGAA · Traditional | 01/07/1982SE |
| K813448 | Potts-Cournand Style NeedleGAA · Traditional | 01/07/1982SE |
| K813461 | Percutaneous Entry Needle, SeldingerDRE · Traditional | 12/29/1981SE |
Questions and answers
When was Spinal Needle cleared by the FDA?
Spinal Needle (K823692) received a 510(k) decision of Substantially Equivalent on January 7, 1983, 30 days after the submission was received.
What is the product code of K823692?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.