BSP
- Product code
- BSP
- Device name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5150
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 152 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243690 | 2025-07-01 | PAJUNK GmbH Medizintechnologie | SonoMSK | |
| K243682 | 2025-06-27 | PAJUNK GmbH Medizintechnologie | SonoPlex STIM; SonoPlex II | |
| K250774 | 2025-06-25 | PAJUNK GmbH Medizintechnologie | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | |
| K243525 | 2025-03-24 | PAJUNK GmbH Medizintechnologie | SonoTAP and SonoTAP II | |
| K241953 | 2024-11-22 | PAJUNK GmbH Medizintechnologie | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | |
| K241954 | 2024-09-11 | PAJUNK GmbH Medizintechnologie | SonoBlock; SonoBlock II | |
| K240253 | 2024-03-21 | Aerin Medical, Inc. | Reach Needle |
Official FDA classification page: BSP
Classification and pathway per current FDA publications. Data from openFDA (CC0).