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GDF — Guide, Needle, Surgical Class I

FDA Device Classification

Classification Details

Product Code
GDF
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K031173needle tech productsNEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 4001July 23, 2003
K950311global medical productsGLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREMay 26, 1995
K950007united states surgical, a division of tyco healthcSURGICAL INSTRUMENT GUIDEMarch 15, 1995
K945124promexBREAST LESION LOCALIZATION NEEDLENovember 22, 1994
K944942promedicalBREAST LESION LOCALIZATION NEEDLENovember 4, 1994
K935538bauer medicalBAUER TEMNO COAXIAL NEEDLEFebruary 22, 1994
K935457bip usaLOCALIZATION WIRE OR MARKER - SURGICALFebruary 17, 1994
K923840guardian angel productsNEEDLE-GRABBERJuly 13, 1993
K923835guardian angel productsTHE ELEVENTH FINGERJuly 9, 1993
K925875bip usaHORIZONTAL NEEDLE GUIDE ATTACHMENTApril 6, 1993
K924270core medicalBREAST LESION LOCALIZATION NEEDLESeptember 23, 1992
K923120angiodynamics, div. e-z-emMICROGUIDE LESION MARKING SYSTEMSeptember 1, 1992
K914941manan medical productsSIMON BREAST LESION LOCALIZATION NEEDLEMay 14, 1992
K920816e-z-emPERCUGUIDE LESION MARKINGApril 21, 1992
K904172dlpACCUPLACE (TM)November 21, 1990
K900903milex productsKOPANS HOOKWIRE LESION LOCALIZATION NEEDLEMay 3, 1990
K890229kinetic medical productsSURGICAL NEEDLE HOLDERSJanuary 27, 1989
K890211kinetic medical productsMICROSURGICAL NEEDLE HOLDERSJanuary 27, 1989
K890228kinetic medical productsSURGICAL NEEDLE GUIDEJanuary 27, 1989
K882036buckman coWILLIAMS ACS MARKER NEEDLEJuly 27, 1988