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510(k) K971645

REGANES SPINAL NEEDLE (VARIOUS) by Avid N.I.T., Inc. — Product Code MIA

K971645 is an FDA 510(k) premarket notification submitted by Avid N.I.T., Inc. for the device "REGANES SPINAL NEEDLE (VARIOUS)". The FDA issued a decision of Substantially Equivalent on August 1, 1997. The device falls under product code MIA (Needle, Spinal, Short Term), a Class II device regulated under 21 CFR 868.5150. Avid N.I.T., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1997
Date Received
May 5, 1997
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 Avid N.I.T., Inc.

  • K014246 — AVID-NIT NERVE STIMULATION NEEDLES (July 16, 2002)
  • K013231 — AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ (December 3, 2001)
  • K983218 — N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE (November 6, 1998)
  • K972595 — ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER (May 20, 1998)
  • K972554 — REGANES RADIONUCLIDE SEED MAGAZINE (February 17, 1998)
  • K973037 — N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 (January 27, 1998)
  • K973638 — N.I.T., INC. NEEDLE GUIDING TEMPLATE (December 23, 1997)
  • K945965 — ATRAUMATIC PENCIL POINT SPINAL NEEDLE (August 2, 1995)

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)
  • 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