Epidural Needle
FDA 510(k) K980536 · Manan Medical Products, Inc.
510(k) numberK980536
Submission
- Device name
- Epidural Needle
- Applicant
- Manan Medical Products, Inc.
Northbrook, IL, US - Received
- February 11, 1998
- Decision date
- July 31, 1998
- 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 |
|---|---|---|
| K052802 | Manan Bio-Cut Soft Tissue Biopsy NeedleKNW · Special | 11/01/2005SE |
| K011209 | Manan Spritacre Spinal NeedlesBSP · Traditional | 06/26/2001SE |
| K983620 | Manan Spinal NeedlesBSP · Traditional | 01/08/1999SE |
| K981386 | Manan Blunt NeedleFPA · Traditional | 06/29/1998SE |
| K980211 | MRI Chiba,Spinal,Breast Localization,Automatic Cutting NeedlesKNW · Traditional | 02/06/1998SE |
| K974446 | Manan Automatic Cutting NeedleKNW · Traditional | 01/08/1998SE |
| K962977 | MRI Compatible Biopsy NeedlesKNW · Traditional | 10/09/1997SE |
| K963767 | Manan V.S. Access Needle/SetFGE · Traditional | 05/16/1997SE |
| K961986 | Manan D BagEXF · Traditional | 03/13/1997SE |
| K962001 | Manan Pediatric Bone Marrow Access NeedleFMI · Traditional | 01/10/1997SE |
Questions and answers
When was Epidural Needle cleared by the FDA?
Epidural Needle (K980536) received a 510(k) decision of Substantially Equivalent on July 31, 1998, 170 days after the submission was received.
What is the product code of K980536?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.