SonoMSK
FDA 510(k) K243690 · PAJUNK GmbH Medizintechnologie
510(k) numberK243690
Submission
- Device name
- SonoMSK
- Applicant
- PAJUNK GmbH Medizintechnologie
Geisingen, DE - Received
- November 29, 2024
- Decision date
- July 1, 2025
- 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 |
|---|---|---|---|
| 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 |
| K203668 | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles…BSP · Traditional | Myco Medical Supplies, Inc. | 09/29/2021SE |
More from Myco Medical Supplies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243682 | SonoPlex STIM; SonoPlex IIBSP · Traditional | 06/27/2025SE |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureBSP · Traditional | 06/25/2025SE |
| K243525 | SonoTAP and SonoTAP IIBSP · Traditional | 03/24/2025SE |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyBSP · Traditional | 11/22/2024SE |
| K241954 | SonoBlock; SonoBlock IIBSP · Traditional | 09/11/2024SE |
| K230701 | Stim2GoIPF · Traditional | 11/24/2023SE |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0HAW · Special | 02/22/2023SE |
| K220897 | Disposable Brain Biopsy Needle 2.0HAW · Traditional | 08/17/2022SE |
| K202699 | E-Cath STIM acc. TsuiCAZ · Special | 12/29/2020SE |
| K190663 | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6BSN · Traditional | 06/17/2019SE |
Questions and answers
When was SonoMSK cleared by the FDA?
SonoMSK (K243690) received a 510(k) decision of Substantially Equivalent on July 1, 2025, 214 days after the submission was received.
What is the product code of K243690?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.