Needle, Spinal, Short Term
The Short-Term Spinal Needle is a slender, hollow needle used to access the subarachnoid space of the spinal canal for the purpose of administering spinal anesthesia or collecting cerebrospinal fluid samples during short-duration procedures. It is classified as a Class 2 device under 21 CFR 868.5150 and requires 510(k) premarket notification, falling under the Anesthesiology medical specialty. It is subject to general and special controls and carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MIA
- Device Class
- FDA class 2
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K172800 | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors | Jun 14, 2018 | Substantially Equivalent | Smiths Medical Asd, Inc. |
| K051860 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | Aug 22, 2005 | Substantially Equivalent | Epimed International, Inc. |
| K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | Jan 29, 1999 | Substantially Equivalent | Sims Portex, Inc. |
| K982269 | CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA | Jul 23, 1998 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K971645 | REGANES SPINAL NEEDLE (VARIOUS) | Aug 01, 1997 | Substantially Equivalent | Avid N.I.T., Inc. |
| K970997 | NEO-CARE LUMBER PUNCTURE KIT | May 22, 1997 | Substantially Equivalent | Klein-Baker Medical, Inc. |
| K961324 | GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES | Jul 02, 1996 | Substantially Equivalent | Global Medical Prods, Inc. |
| K960405 | SPINAL NEEDLE | Feb 28, 1996 | Substantially Equivalent | Promex, Inc. |
| K942442 | ACUFEX T-FIX DELIVERY SYSTEM | Dec 05, 1994 | Substantially Equivalent | Acufex Microsurgical, Inc. |
| K904380 | SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM | Apr 08, 1993 | Unknown | Custom Medical Concepts, Inc. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.