Atraumatic Pencil Point Spinal Needle
FDA 510(k) K945965 · Avid N.I.T., Inc.
510(k) numberK945965
Submission
- Device name
- Atraumatic Pencil Point Spinal Needle
- Applicant
- Avid N.I.T., Inc.
Tarpon Springs, FL, US - Received
- December 7, 1994
- Decision date
- August 2, 1995
- 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 |
|---|---|---|
| K014246 | Avid-Nit Nerve Stimulation NeedlesCAZ · Traditional | 07/16/2002SE |
| K013231 | Avid-Nit Plastic Hub Lutz Epidural Needle,Model RP2035L, Avid-Nit Metal Hub Lutz…BSP · Traditional | 12/03/2001SE |
| K983218 | N,I.T., Inc. Automatic Cutting Biopsy NeedleFCG · Traditional | 11/06/1998SE |
| K972595 | Aldrete Epidural Needle Without IntroducerBSP · Traditional | 05/20/1998SE |
| K972554 | Reganes Radionuclide Seed MagazineIWJ · Traditional | 02/17/1998SE |
| K973037 | N.I.T., Inc. Radionuclide Seed Applicator, Model SA-1000IWJ · Traditional | 01/27/1998SE |
| K973638 | N.I.T., Inc. Needle Guiding TemplateIWJ · Traditional | 12/23/1997SE |
| K971645 | Reganes Spinal Needle (Various)MIA · Traditional | 08/01/1997SE |
Questions and answers
When was Atraumatic Pencil Point Spinal Needle cleared by the FDA?
Atraumatic Pencil Point Spinal Needle (K945965) received a 510(k) decision of Substantially Equivalent on August 2, 1995, 238 days after the submission was received.
What is the product code of K945965?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.