SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
FDA 510(k) K151069 · Spectra Medical Devices, Inc.
510(k) numberK151069
Submission
- Device name
- SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
- Applicant
- Spectra Medical Devices, Inc.
Wilmington, MA, US - Received
- April 21, 2015
- Decision date
- February 5, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K163292 | Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block CrawfordBSP · Traditional | 09/08/2017SE |
| K142791 | Spectra Soft Tissue Biopsy NeedlesKNW · Traditional | 01/21/2015SE |
| K103740 | Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML AmpuleNGT · Traditional | 07/29/2011SE |
| K082689 | Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, AmpuleNGT · Traditional | 03/20/2009SE |
| K082580 | Spectra Guidewire Introducer NeedleDYB · Traditional | 12/08/2008SE |
| K082674 | Spectra-Glass Lor (Loss of Resistance Syringe, 5CC Metal L/S or L/L Tip, Spectra-Glass…FMF · Traditional | 11/28/2008SE |
| K081524 | Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML Plastic…FMF · Traditional | 07/29/2008SE |
Questions and answers
When was SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle cleared by the FDA?
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle (K151069) received a 510(k) decision of Substantially Equivalent on February 5, 2016, 290 days after the submission was received.
What is the product code of K151069?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.