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510(k) K982269

CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA by Allegiance Healthcare Corp. — Product Code MIA

K982269 is an FDA 510(k) premarket notification submitted by Allegiance Healthcare Corp. for the device "CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA". The FDA issued a decision of Substantially Equivalent on July 23, 1998. The device falls under product code MIA (Needle, Spinal, Short Term), a Class II device regulated under 21 CFR 868.5150. Allegiance Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1998
Date Received
June 29, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Spinal, Short Term
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Allegiance Healthcare Corp.

  • K023673 — AIRLIFE DEMAND NASAL CANNULA (May 2, 2003)
  • K023419 — TRILAMINATE DRAPES/TIBURON (February 11, 2003)
  • K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES (January 15, 2003)
  • K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN (January 9, 2003)
  • K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (December 18, 2002)
  • K023425 — DRAPES WITH ABSORBENT REINFORCEMENT (November 6, 2002)
  • K022765 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 11, 2002)
  • K023170 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 9, 2002)
  • K023167 — BREATHABLE SURGICAL GOWN (October 2, 2002)
  • K012931 — GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM (August 20, 2002)

Other clearances for product code MIA

  • K172800 — Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point (June 14, 2018)
  • K051860 — FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 (August 22, 2005)
  • K983858 — SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES (January 29, 1999)
  • K971645 — REGANES SPINAL NEEDLE (VARIOUS) (August 1, 1997)
  • K970997 — NEO-CARE LUMBER PUNCTURE KIT (May 22, 1997)
  • K961324 — GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEED (July 2, 1996)
  • K960405 — SPINAL NEEDLE (February 28, 1996)
  • K942442 — ACUFEX T-FIX DELIVERY SYSTEM (December 5, 1994)
  • K904380 — SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM (April 8, 1993)

FDA data resources