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510(k) K900903

KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE by Milex Products, Inc. — Product Code GDF

K900903 is an FDA 510(k) premarket notification submitted by Milex Products, Inc. for the device "KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE". The FDA issued a decision of Substantially Equivalent on May 3, 1990. The device falls under product code GDF (Guide, Needle, Surgical), a Class I device regulated under 21 CFR 878.4800. Milex Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1990
Date Received
February 27, 1990
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 Milex Products, Inc.

  • K001545 — PIPET CURET (June 15, 2000)
  • K904774 — INGLAT-O-BALL (December 7, 1990)
  • K904026 — INFLAT-O-BALL (October 10, 1990)
  • K882628 — ENDO C BRUSH (July 25, 1988)
  • K862410 — MILEX KEGEL PERINEAL EXERCISER (July 31, 1986)
  • K861385 — MILEX BARTHOLIN GLAND CATHETER (June 16, 1986)
  • K760264 — CURETTE, PROPOSED TIS-U-TRAP, METAL (October 6, 1976)

Other clearances for product code GDF

  • K031173 — NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 4001 (July 23, 2003)
  • 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)

FDA data resources