Holgrath Plastic-Hub Epidural Needle
FDA 510(k) K944906 · Holgrath Medical Technologies, Inc.
510(k) numberK944906
Submission
- Device name
- Holgrath Plastic-Hub Epidural Needle
- Applicant
- Holgrath Medical Technologies, Inc.
Cheshire, CT, US - Received
- October 5, 1994
- Decision date
- June 7, 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 |
|---|---|---|
| K954835 | Holgrath Combined Spinal Epidural Needle SetCAZ · Traditional | 01/31/1996SE |
| K946047 | Holgrath Metal-Hub, Epidural NeedleBSP · Traditional | 07/25/1995SE |
| K944908 | Holgrath Plastic-Hub, Coical Point Spinal NeedleBSP · Traditional | 06/07/1995SE |
| K944907 | Holgrath Plastic-Hub, Quincke Spinal NeedleBSP · Traditional | 06/07/1995SE |
| K944905 | Holgrath Plastic-Hub, Whitacre Style Spinal NeedleBSP · Traditional | 06/07/1995SE |
Questions and answers
When was Holgrath Plastic-Hub Epidural Needle cleared by the FDA?
Holgrath Plastic-Hub Epidural Needle (K944906) received a 510(k) decision of Substantially Equivalent on June 7, 1995, 245 days after the submission was received.
What is the product code of K944906?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.