Spinal Anesthesia Needles and Introducer Needles
FDA 510(k) K983858 · Sims Portex, Inc.
510(k) numberK983858
Submission
- Device name
- Spinal Anesthesia Needles and Introducer Needles
- Applicant
- Sims Portex, Inc.
Keene, NH, US - Received
- November 2, 1998
- Decision date
- January 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K960405 | Spinal NeedleMIA · Traditional | Promex, Inc. | 02/28/1996SE |
| 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 |
|---|---|---|
| K012277 | Portex Ring Pessary Pvc-Non Sterile; Portex Ring Pessary Polythene- Non SterileHHW · Traditional | 02/11/2002SE |
| K012068 | Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S…MQE · Traditional | 08/03/2001SE |
| K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro…FMI · Traditional | 07/12/2001SE |
| K002201 | Electrostatic Hydrophobic Breathing FilterCAH · Traditional | 02/05/2001SE |
| K002506 | Breathing Filter for Disposable Anesthesia Breathing CircuitCAH · Traditional | 12/14/2000SE |
| K001555 | Suresample-Wallace Endometrial Sampler, Endo 26HHK · Traditional | 08/02/2000SE |
| K001318 | CPAP System, Model 102001BYE · Traditional | 07/20/2000SE |
| K993619 | Csecure Combined Spinal/Epidural Anesthesia System with LockBSP · Traditional | 04/28/2000SE |
| K000628 | Wallace Oocyte Retrieval SET-16G, Model MEONS1633; Wallace Oocyte Retrieval SET-17G…MQE · Traditional | 03/13/2000SE |
| K994275 | Sims Portex Anesthesia CatheterFRN · Traditional | 02/22/2000SE |
Questions and answers
When was Spinal Anesthesia Needles and Introducer Needles cleared by the FDA?
Spinal Anesthesia Needles and Introducer Needles (K983858) received a 510(k) decision of Substantially Equivalent on January 29, 1999, 88 days after the submission was received.
What is the product code of K983858?
The FDA product code is MIA – Needle, Spinal, Short Term, a Class II (moderate risk) device regulated under 21 CFR 868.5150.