510(k) K014246

AVID-NIT NERVE STIMULATION NEEDLES by Avid N.I.T., Inc. — Product Code CAZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 16, 2002
Date Received: December 26, 2001
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Anesthesia Conduction Kit
Device Class: Class II
Regulation Number: 868.5140
Review Panel: AN
Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Avid N.I.T., Inc.

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)
K971645 — REGANES SPINAL NEEDLE (VARIOUS) (August 1, 1997)
K945965 — ATRAUMATIC PENCIL POINT SPINAL NEEDLE (August 2, 1995)

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