Spinal Needle
FDA 510(k) K960405 · Promex, Inc.
510(k) numberK960405
Submission
- Device name
- Spinal Needle
- Applicant
- Promex, Inc.
Indianapolis, IN, US - Received
- January 29, 1996
- Decision date
- February 28, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MIA – Needle, Spinal, Short Term
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5150
- Specialty
- Anesthesiology
Other 510(k)s with product code MIA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172800 | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal…MIA · Traditional | Smiths Medical Asd, Inc. | 06/14/2018SE |
| K051860 | Flexible Introducer Cannula, Model 135-1837MIA · Traditional | Epimed International, Inc. | 08/22/2005SE |
| K983858 | Spinal Anesthesia Needles and Introducer NeedlesMIA · Traditional | Sims Portex, Inc. | 01/29/1999SE |
| K982269 | Clear Hub Spinal Needle 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA and 27GAMIA · Traditional | Allegiance Healthcare Corp. | 07/23/1998SE |
| K971645 | Reganes Spinal Needle (Various)MIA · Traditional | Avid N.I.T., Inc. | 08/01/1997SE |
| K970997 | Neo-Care Lumber Puncture KitMIA · Traditional | Klein-Baker Medical, Inc. | 05/22/1997SE |
| K961324 | Global Medical Products Spinal,Conical Tip (Sprottle Style), Whitacre Style NeedlesMIA · Traditional | Global Medical Prods, Inc. | 07/02/1996SE |
| K942442 | Acufex T-Fix Delivery SystemMIA · Traditional | Acufex Microsurgical, Inc. | 12/05/1994SE |
| K904380 | Spinal Cord Access Epidural Introducer SystemMIA · Traditional | Custom Medical Concepts, Inc. | 04/08/1993SESK |
More from Custom Medical Concepts, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023450 | Biopsy Site Tissue Marker DeviceNEU · Traditional | 12/19/2002SE |
| K022634 | Co-Axial Introducer NeedleDYB · Traditional | 11/06/2002SE |
| K010400 | Vacuum Assisted Core Biopsy DeviceKNW · Traditional | 07/24/2001SE |
| K011270 | Automated Core Biopsy DeviceFCG · Traditional | 06/22/2001SE |
| K001132 | Bone Biopsy NeedleKNW · Traditional | 05/01/2000SE |
| K994272 | Automated Core Biopsy DeviceKNW · Traditional | 01/07/2000SE |
| K993435 | Manual Bone Marrow Biopsy DeviceKNW · Traditional | 12/06/1999SE |
| K973184 | Prostate Seeding NeedleIWJ · Traditional | 11/21/1997SE |
| K972865 | Promex ENT Tissue Removal SystemERL · Traditional | 09/29/1997SE |
| K961078 | Automated Vitrectomy DeviceHQE · Traditional | 06/14/1996SE |
Questions and answers
When was Spinal Needle cleared by the FDA?
Spinal Needle (K960405) received a 510(k) decision of Substantially Equivalent on February 28, 1996, 30 days after the submission was received.
What is the product code of K960405?
The FDA product code is MIA – Needle, Spinal, Short Term, a Class II (moderate risk) device regulated under 21 CFR 868.5150.