Product code MIA— Anesthesiology
ACUFEX T-FIX DELIVERY SYSTEM
- Classification name
- Needle, Spinal, Short Term
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code MIA
FDA has cleared devices under product code MIA between 1993 and 2018, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2005
- 1999
- 1998
- 1997
- 1996
- 1994
- 1993
Top applicants under product code MIA
Recent clearances under product code MIA
- K172800 — Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors
- K051860 — FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
- K983858 — SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
- K982269 — CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA
- K971645 — REGANES SPINAL NEEDLE (VARIOUS)
- K970997 — NEO-CARE LUMBER PUNCTURE KIT
- K961324 — GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES
- K960405 — SPINAL NEEDLE
- K942442 — ACUFEX T-FIX DELIVERY SYSTEM
- K904380 — SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.