Laurimed Spinal Injection System
FDA 510(k) K091818 · Laurimed, LLC
510(k) numberK091818
Submission
- Device name
- Laurimed Spinal Injection System
- Applicant
- Laurimed, LLC
Redwood City, CA, US - Received
- June 18, 2009
- Decision date
- September 23, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderERL · Traditional | 03/09/2017SE |
| K161101 | PolypVac Microdebrider (3.3mm and 4.0mm)ERL · Special | 06/22/2016SE |
| K133133 | Laurimed Polypvac MicrodebriderERL · Traditional | 12/23/2013SE |
| K090815 | Percutaneous Discectomy SystemHRX · Traditional | 05/21/2009SE |
| K083909 | Spinal Injection SystemBSP · Traditional | 03/18/2009SE |
| K082194 | Laurimed Percutaneous Discectomy System, Model FG-000002HRX · Traditional | 08/28/2008SE |
| K080140 | Laurimed Spinal Injection SystemBSP · Traditional | 05/09/2008SE |
Questions and answers
When was Laurimed Spinal Injection System cleared by the FDA?
Laurimed Spinal Injection System (K091818) received a 510(k) decision of Substantially Equivalent on September 23, 2009, 97 days after the submission was received.
What is the product code of K091818?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.