Entellus Medical Reinforced Anesthesia Needle
FDA 510(k) K163435 · Entellus Medical, Inc.
510(k) numberK163435
Submission
- Device name
- Entellus Medical Reinforced Anesthesia Needle
- Applicant
- Entellus Medical, Inc.
Plymouth, MN, US - Received
- December 7, 2016
- Decision date
- April 5, 2017
- 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 |
|---|---|---|
| K220027 | Audion ET dilation systemPNZ · Traditional | 04/12/2022SE |
| K163509 | XprESS ENT Dilation SystemPNZ · Traditional | 04/05/2017SE |
| K152435 | PassAssist LED Light FiberLRC · Traditional | 11/20/2015SE |
| K152434 | XprESS Multi-Sinus Dilation SystemLRC · Traditional | 11/20/2015SE |
| K142252 | XprESS Multi-Sinus Dilation ToolLRC · Special | 10/17/2014SE |
| K141916 | Pathassist LED Light FiberLRC · Special | 08/07/2014SE |
| K133563 | Pathassist Light SeekerLRC · Special | 12/20/2013SE |
| K132440 | Xpress Multi-Sinus Dilation ToolLRC · Special | 10/04/2013SE |
| K130503 | Pathassist LED Light FiberLRC · Traditional | 06/11/2013SE |
| K121943 | Xpress Multi-Sinus Dilation ToolLRC · Special | 08/22/2012SE |
Questions and answers
When was Entellus Medical Reinforced Anesthesia Needle cleared by the FDA?
Entellus Medical Reinforced Anesthesia Needle (K163435) received a 510(k) decision of Substantially Equivalent on April 5, 2017, 119 days after the submission was received.
What is the product code of K163435?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.