Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18G
FDA 510(k) K090261 · Smiths Medical Asd, Inc.
510(k) numberK090261
Submission
- Device name
- Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18G
- Applicant
- Smiths Medical Asd, Inc.
Keene, NH, US - Received
- February 3, 2009
- Decision date
- May 1, 2009
- 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
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| 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 |
|---|---|---|
| K232943 | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space SyringeQNQ · Traditional | 05/31/2024SE |
| K210833 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy…JOH · Traditional | 11/26/2021SE |
| K211634 | Hypodermic Needle-Pro EDGE Safety DeviceFMI · Special | 08/26/2021SE |
| K192375 | Intellifuse Administration and Intellifuse Blood Administration SetsFPA · Traditional | 09/18/2020SE |
| K181699 | Level 1 Convective WarmerDWJ · Traditional | 07/26/2018SE |
| K172800 | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal…MIA · Traditional | 06/14/2018SE |
| K172823 | Portex NRFit Epidural NeedlesBSP · Traditional | 06/12/2018SE |
| K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of…BSP · Traditional | 06/01/2018SE |
| K172592 | CADD Yellow High Volume Administration Set with NRFit connectorPWH · Traditional | 05/17/2018SE |
| K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…JOH · Traditional | 05/08/2018SE |
Questions and answers
When was Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18G cleared by the FDA?
Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18G (K090261) received a 510(k) decision of Substantially Equivalent on May 1, 2009, 87 days after the submission was received.
What is the product code of K090261?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.