Product code MIA
- Device name
- Needle, Spinal, Short Term
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5150
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172800 | Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors | Smiths Medical Asd, Inc. | 2018-06-14 |
| K051860 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | Epimed International, Inc. | 2005-08-22 |
| K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | Sims Portex, Inc. | 1999-01-29 |
| K982269 | CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA | Allegiance Healthcare Corp. | 1998-07-23 |
| K971645 | REGANES SPINAL NEEDLE (VARIOUS) | Avid N.I.T., Inc. | 1997-08-01 |
| K970997 | NEO-CARE LUMBER PUNCTURE KIT | Klein-Baker Medical, Inc. | 1997-05-22 |
| K961324 | GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES | Global Medical Prods, Inc. | 1996-07-02 |
| K960405 | SPINAL NEEDLE | Promex, Inc. | 1996-02-28 |
| K942442 | ACUFEX T-FIX DELIVERY SYSTEM | Acufex Microsurgical, Inc. | 1994-12-05 |
| K904380 | SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM | Custom Medical Concepts, Inc. | 1993-04-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10809160323687 | Halyard | AVID MEDICAL, INC. | 2020-12-11 |
| 10809160323632 | Halyard | AVID MEDICAL, INC. | 2020-12-11 |
| 10809160323625 | Halyard | AVID MEDICAL, INC. | 2020-12-11 |
| 10809160323618 | Halyard | AVID MEDICAL, INC. | 2020-12-11 |
| 10809160323502 | Halyard | AVID MEDICAL, INC. | 2020-12-11 |
| 10809160323649 | Halyard | AVID MEDICAL, INC. | 2020-12-11 |
| 10809160323656 | Halyard | AVID MEDICAL, INC. | 2020-12-11 |
| 10809160323663 | Halyard | AVID MEDICAL, INC. | 2020-12-11 |
| 10809160323670 | Halyard | AVID MEDICAL, INC. | 2020-12-11 |
| 10809160323694 | Halyard | AVID MEDICAL, INC. | 2020-12-11 |
| 10809160323700 | Halyard | AVID MEDICAL, INC. | 2020-12-11 |
| 15019517070637 | Portex | ICU MEDICAL, INC. | 2020-03-09 |
| 15019517063479 | Portex | ICU MEDICAL, INC. | 2020-03-09 |
| 15019517063523 | Portex | ICU MEDICAL, INC. | 2020-03-09 |
| 15019517063530 | Portex | ICU MEDICAL, INC. | 2020-03-09 |
| 15019517070576 | Portex | ICU MEDICAL, INC. | 2020-03-09 |
| 15019517070606 | Portex | ICU MEDICAL, INC. | 2020-03-09 |
| 10080196741694 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-24 |
| 10080196163687 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10809160061534 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 10809160057360 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 10809160004227 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 10809160002919 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 10809160002865 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 10809160002858 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 10809160002285 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 10809160002254 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 10809160002247 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 10809160002124 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 10809160002117 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |