Sonixgps
FDA 510(k) K121812 · Ultrasonix Medical Corporation
510(k) numberK121812
Submission
- Device name
- Sonixgps
- Applicant
- Ultrasonix Medical Corporation
Monroe, CT, US - Received
- June 20, 2012
- Decision date
- December 2, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K111818 | Sonixgps Needle SensorIYO · Traditional | 06/13/2012SE |
| K113663 | Sonixtablet Ultrasound ScannerIYN · Traditional | 01/25/2012SE |
| K112726 | Sonix Ultrasound ScannerIYN · Traditional | 09/27/2011SE |
| K102997 | Sonixtablet Ultrasound ScannerIYN · Traditional | 12/21/2010SE |
| K093462 | Sonix Ultrasound ScannerITX · Traditional | 11/20/2009SE |
| K083095 | Sonixtouch Ultrasound SystemIYN · Traditional | 10/31/2008SE |
| K080935 | Sonix MDP Ultrasound ScannerIYN · Traditional | 08/06/2008SE |
| K061827 | Sonix Ultrasound ScannerIYN · Traditional | 08/04/2006SE |
| K042326 | Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerIYN · Traditional | 09/16/2004SE |
| K020630 | Ultrasonix Ergosonix 500 Ultrasound ScannerIYN · Traditional | 06/13/2002SE |
Questions and answers
When was Sonixgps cleared by the FDA?
Sonixgps (K121812) received a 510(k) decision of Substantially Equivalent on December 2, 2013, 530 days after the submission was received.
What is the product code of K121812?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.