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FZX — Guide, Surgical, Instrument Class I

FDA Device Classification

FDA product code FZX covers "Guide, Surgical, Instrument", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 19 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FZX
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
K914715implant corp. of americaPARALLELING GUIDESFebruary 16, 1994
K871413civco medical instruments coCIVCO STEPPERJuly 14, 1987
K871503amedic usaBIOPSY NEEDLE GUIDE KIT, STERILEJuly 10, 1987
K862564aspen laboratoriesA.C.L. GUIDE KITAugust 18, 1986
K854262meadox surgimedMEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYDecember 24, 1985
K852402north american instrumentNAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERJuly 11, 1985
K842698downs surgicalBRITISH SPINAL FUSION SETSeptember 12, 1984
K841618plastafilTHREADING TUBEAugust 27, 1984
K841619plastafilDRILL GUIDEJuly 11, 1984
K841297techmedicaTECHMEDICA DRILL GUIDEApril 25, 1984
K840835surgical technology laboratoriesSTRAITH DRAIN INSERTERApril 23, 1984
K834350acufex microsurgicalACUFEX DREZ COMMUNICATING DRILL GUIDEMarch 19, 1984
K830720acufex microsurgicalGRAF MENISCAL SUTURE SETJune 16, 1983
K821618medcare productsDISPOSABLE NEEDLE HOLDERSJune 21, 1982
K810888buckeye celluloseBOUNDARY TUBING HOLDERSApril 23, 1981
K810788urology groupSURGICAL TUBE HOLDERApril 17, 1981
K802093howmedicaGABBAY-FRATER SUTURE GUIDESeptember 26, 1980
K792468biosearch medical productsFEEDING TUBE PLACEMENT STYLETDecember 27, 1979
K790872biosearch medical productsENTERIC TUBE GUIDEMay 23, 1979

FDA data resources