MIA — Needle, Spinal, Short Term Class II
FDA product code MIA covers "Needle, Spinal, Short Term", a Class II medical device regulated under 21 CFR 868.5150. Submissions are reviewed by the Anesthesiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MIA
- Device Class
- Class II
- Regulation Number
- 868.5150
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172800 | smiths medical asd | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point | June 14, 2018 |
| K051860 | epimed international | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | August 22, 2005 |
| K983858 | sims portex | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | January 29, 1999 |
| K982269 | allegiance healthcare | CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND | July 23, 1998 |
| K971645 | avid n.i.t | REGANES SPINAL NEEDLE (VARIOUS) | August 1, 1997 |
| K970997 | klein-baker medical | NEO-CARE LUMBER PUNCTURE KIT | May 22, 1997 |
| K961324 | global medical prods | GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEED | July 2, 1996 |
| K960405 | promex | SPINAL NEEDLE | February 28, 1996 |
| K942442 | acufex microsurgical | ACUFEX T-FIX DELIVERY SYSTEM | December 5, 1994 |
| K904380 | custom medical concepts | SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM | April 8, 1993 |