Sono Tap, Tuohy Sono
FDA 510(k) K113207 · Pajunk GmbH
510(k) numberK113207
Submission
- Device name
- Sono Tap, Tuohy Sono
- Applicant
- Pajunk GmbH
Geisingen, DE - Received
- October 31, 2011
- Decision date
- February 29, 2012
- 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 |
|---|---|---|
| K113209 | Chiba SonoKNW · Traditional | 11/21/2011SE |
| K060563 | Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVCAZ · Traditional | 06/02/2006SE |
| K053283 | Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline SetCAZ · Special | 01/12/2006SE |
| K053282 | Adaptable Monopolar Electrodes with Ceramic TipGEI · Special | 12/13/2005SE |
| K043130 | Modification to Pajunk Stimulong Plus Catheter SetsCAZ · Special | 12/21/2004SE |
| K042979 | Modification to: Plexalong SetsBSP · Special | 12/21/2004SE |
| K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesBSP · Traditional | 09/07/2004SE |
| K033018 | Stimulong Plus Catheter Set Model, VariousCAZ · Traditional | 05/05/2004SE |
| K033249 | Pajunk Modular Handle InstrumentsGCJ · Traditional | 03/05/2004SE |
| K023218 | Modification to Plexolong SetsBSP · Special | 03/24/2003SE |
Questions and answers
When was Sono Tap, Tuohy Sono cleared by the FDA?
Sono Tap, Tuohy Sono (K113207) received a 510(k) decision of Substantially Equivalent on February 29, 2012, 121 days after the submission was received.
What is the product code of K113207?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.