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510(k) K961324

GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES by Global Medical Prods, Inc. — Product Code MIA

K961324 is an FDA 510(k) premarket notification submitted by Global Medical Prods, Inc. for the device "GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES". The FDA issued a decision of Substantially Equivalent on July 2, 1996. The device falls under product code MIA (Needle, Spinal, Short Term), a Class II device regulated under 21 CFR 868.5150. Global Medical Prods, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1996
Date Received
April 8, 1996
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 Global Medical Prods, Inc.

  • K962329 — GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10 (September 12, 1996)
  • K952275 — GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB (October 11, 1995)
  • K934256 — GLOBAL MEDICAL CUTTING BIOPSY NEEDLE (March 28, 1994)
  • K871556 — MERIVAARA EMERGENCY PATIENT TROLLEY #436 (April 30, 1987)
  • K863748 — HOSPITAL BED (October 9, 1986)
  • K862959 — MERIVAARA PATIENT TROLLEY - MODEL #416 (September 25, 1986)
  • K862957 — MERIVAARA GERIATRIC CHAIR MODEL 455 (August 21, 1986)
  • K862931 — MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358 (August 7, 1986)

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)
  • K982269 — CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND (July 23, 1998)
  • K971645 — REGANES SPINAL NEEDLE (VARIOUS) (August 1, 1997)
  • K970997 — NEO-CARE LUMBER PUNCTURE KIT (May 22, 1997)
  • 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