Csecure Combined Spinal/Epidural Anesthesia System with Lock
FDA 510(k) K993619 · Sims Portex, Inc.
510(k) numberK993619
Submission
- Device name
- Csecure Combined Spinal/Epidural Anesthesia System with Lock
- Applicant
- Sims Portex, Inc.
Keene, NH, US - Received
- October 26, 1999
- Decision date
- April 28, 2000
- 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 |
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| K001318 | CPAP System, Model 102001BYE · Traditional | 07/20/2000SE |
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| K994275 | Sims Portex Anesthesia CatheterFRN · Traditional | 02/22/2000SE |
| K991861 | 1ST Response Infant Manual Resuscitator, Bag Resevoir, 1ST Response Pediatric Manual…BTM · Traditional | 01/18/2000SE |
Questions and answers
When was Csecure Combined Spinal/Epidural Anesthesia System with Lock cleared by the FDA?
Csecure Combined Spinal/Epidural Anesthesia System with Lock (K993619) received a 510(k) decision of Substantially Equivalent on April 28, 2000, 185 days after the submission was received.
What is the product code of K993619?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.