Panels › Anesthesiology › Product code MIA · Class 2
Needle, Spinal, Short Term
Regulation 868.5150
0510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MIA
| Company | 510(k)s | Recalls |
|---|---|---|
| Acufex Microsurgical, Inc. | 1 | 0 |
| Allegiance Healthcare Corp. | 1 | 0 |
| Avid N.I.T., Inc. | 1 | 0 |
| Custom Medical Concepts, Inc. | 1 | 0 |
| Epimed International, Inc. | 1 | 0 |
| Global Medical Prods, Inc. | 1 | 0 |
| Klein-Baker Medical, Inc. | 1 | 0 |
| Promex, Inc. | 1 | 0 |
| Sims Portex, Inc. | 1 | 0 |
| Smiths Medical Asd, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 2018 | K172800 | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors Smiths Medical Asd, Inc. | MIA |
| Aug 22, 2005 | K051860 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 Epimed International, Inc. | MIA |
| Jan 29, 1999 | K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES Sims Portex, Inc. | MIA |
| Jul 23, 1998 | K982269 | CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA Allegiance Healthcare Corp. | MIA |
| Aug 1, 1997 | K971645 | REGANES SPINAL NEEDLE (VARIOUS) Avid N.I.T., Inc. | MIA |
| May 22, 1997 | K970997 | NEO-CARE LUMBER PUNCTURE KIT Klein-Baker Medical, Inc. | MIA |
| Jul 2, 1996 | K961324 | GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES Global Medical Prods, Inc., CA | MIA |
| Feb 28, 1996 | K960405 | SPINAL NEEDLE Promex, Inc. | MIA |
| Dec 5, 1994 | K942442 | ACUFEX T-FIX DELIVERY SYSTEM Acufex Microsurgical, Inc. | MIA |
| Apr 8, 1993 | K904380 | SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM Custom Medical Concepts, Inc. | MIA |
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