MIA · Needle, Spinal, Short Term
Anesthesiology · 21 CFR 868.5150 · Class 2
Overview
| Product Code | MIA |
|---|---|
| Device Name | Needle, Spinal, Short Term |
| Regulation | 21 CFR 868.5150 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
Classification Rationale
Class II (performance standards).
Cleared Devices (10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172800 | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors | Smiths Medical Asd, Inc. | Jun 14, 2018 | SESE |
| K051860 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | Epimed International, Inc. | Aug 22, 2005 | SESE |
| K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | Sims Portex, Inc. | Jan 29, 1999 | SESE |
| K982269 | CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA | Allegiance Healthcare Corp. | Jul 23, 1998 | SESE |
| K971645 | REGANES SPINAL NEEDLE (VARIOUS) | Avid N.I.T., Inc. | Aug 1, 1997 | SESE |
| K970997 | NEO-CARE LUMBER PUNCTURE KIT | Klein-Baker Medical, Inc. | May 22, 1997 | SESE |
| K961324 | GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES | Global Medical Prods, Inc. | Jul 2, 1996 | SESE |
| K960405 | SPINAL NEEDLE | Promex, Inc. | Feb 28, 1996 | SESE |
| K942442 | ACUFEX T-FIX DELIVERY SYSTEM | Acufex Microsurgical, Inc. | Dec 5, 1994 | SESE |
| K904380 | SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM | Custom Medical Concepts, Inc. | Apr 8, 1993 | SESK |
Top Applicants
- Smiths Medical Asd, Inc. — 1 clearance
- Sims Portex, Inc. — 1 clearance
- Promex, Inc. — 1 clearance
- Klein-Baker Medical, Inc. — 1 clearance
- Global Medical Prods, Inc. — 1 clearance
