Phoenix Epidural & Spinal Needles
FDA 510(k) K990519 · Myco Medical Supplies, Inc.
510(k) numberK990519
Submission
- Device name
- Phoenix Epidural & Spinal Needles
- Applicant
- Myco Medical Supplies, Inc.
Cary, NC, US - Received
- February 18, 1999
- Decision date
- June 2, 2000
- 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 |
|---|---|---|
| K203668 | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles…BSP · Traditional | 09/29/2021SE |
| K173279 | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube HolderFMI · Traditional | 05/14/2018SE |
| K090426 | VAKU-8 Blood Collection NeedlesFMI · Traditional | 06/12/2009SE |
| K042504 | Cathy Sterile Disposable I.V. Cannula with CatheterFOZ · Traditional | 01/19/2006SE |
| K000592 | Unolok Plus Infusion Set and VAKU-8 Plus Blood Collection SetFPA · Traditional | 04/12/2001SE |
| K982646 | Ailee Sutures and Ailee NeedlesGAL · Traditional | 06/02/1999SE |
| K990388 | Tutoplus IV Administration SetFPA · Traditional | 03/29/1999SE |
| K982098 | Tutodrop 1 and Tutodrop 2FPA · Traditional | 03/01/1999SE |
| K963364 | Glass Van Glass SyringesFMF · Traditional | 05/01/1998SE |
| K953252 | Disposable Scalp Vein Infusion SetFOZ · Traditional | 11/26/1996SE |
Questions and answers
When was Phoenix Epidural & Spinal Needles cleared by the FDA?
Phoenix Epidural & Spinal Needles (K990519) received a 510(k) decision of Substantially Equivalent on June 2, 2000, 470 days after the submission was received.
What is the product code of K990519?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.