Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
FDA 510(k) K163292 · Spectra Medical Devices
510(k) numberK163292
Submission
- Device name
- Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
- Applicant
- Spectra Medical Devices
Wilmington, MA, US - Received
- November 22, 2016
- Decision date
- September 8, 2017
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K151069 | SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction NeedleBSP · Traditional | 02/05/2016SE |
| 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 Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford cleared by the FDA?
Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford (K163292) received a 510(k) decision of Substantially Equivalent on September 8, 2017, 290 days after the submission was received.
What is the product code of K163292?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.