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510(k) K031173

NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 by Needle Tech Products, Inc. — Product Code GDF

K031173 is an FDA 510(k) premarket notification submitted by Needle Tech Products, Inc. for the device "NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013". The FDA issued a decision of Substantially Equivalent on July 23, 2003. The device falls under product code GDF (Guide, Needle, Surgical), a Class I device regulated under 21 CFR 878.4800. Needle Tech Products, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2003
Date Received
April 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Needle, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Needle Tech Products, Inc.

  • K143252 — Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (ora (April 23, 2015)
  • K100665 — MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX (June 24, 2010)

Other clearances for product code GDF

  • K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (May 26, 1995)
  • K950007 — SURGICAL INSTRUMENT GUIDE (March 15, 1995)
  • K945124 — BREAST LESION LOCALIZATION NEEDLE (November 22, 1994)
  • K944942 — BREAST LESION LOCALIZATION NEEDLE (November 4, 1994)
  • K935538 — BAUER TEMNO COAXIAL NEEDLE (February 22, 1994)
  • K935457 — LOCALIZATION WIRE OR MARKER - SURGICAL (February 17, 1994)
  • K923840 — NEEDLE-GRABBER (July 13, 1993)
  • K923835 — THE ELEVENTH FINGER (July 9, 1993)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)
  • K924270 — BREAST LESION LOCALIZATION NEEDLE (September 23, 1992)

FDA data resources