Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B
FDA 510(k) K063071 · Kyphon, Inc.
510(k) numberK063071
Submission
- Device name
- Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B
- Applicant
- Kyphon, Inc.
Sunnyvale, CA, US - Received
- October 6, 2006
- Decision date
- April 13, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K073516 | Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…BSP · Traditional | 02/21/2008SE |
| K061210 | Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…BSP · Special | 06/27/2006SE |
| K041454 | Kyphx Xpander Inflatable Bone Tamps MODEL#KO8A,KO9A,K13AHRX · Traditional | 07/09/2004SE |
| K041584 | Kyphx Hv-R Bone Cement, Model C01ANDN · Traditional | 07/07/2004SE |
| K033801 | Kyphx Hv-R, Model C01ANDN · Traditional | 04/01/2004SE |
| K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AHRX · Traditional | 09/15/2003SE |
| K010246 | Kyphx Inflatable Bone Tamp, Size 20/3,MODEL K01A, Kyphx Inflatable Bone Tamp, Size 15/3…HRX · Traditional | 02/14/2001SE |
| K981251 | Kyphon Inflatable Bone TampHRX · Traditional | 07/02/1998SE |
Questions and answers
When was Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B cleared by the FDA?
Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B (K063071) received a 510(k) decision of Substantially Equivalent on April 13, 2007, 189 days after the submission was received.
What is the product code of K063071?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.